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Bellweather Cases Starting for DePuy Hip Replacment, Metal on metal Hip Replacement lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Bellwether Trials Scheduled to Move Forward in DePuy Hip Litigation

 

DePuy metal hips have been linked to a number of serious complications.

The first bellwether trials in the pending DePuy hip litigation are scheduled to begin later this year. The handful of plaintiffs involved in the trials represent just a few of the thousands of individuals who filed suit against Johnson & Johnson and DePuy Orthopedics after allegedly being injured by a defective metal hip implant.

According to a Bloomberg report, the first bellwether case is scheduled to go to trial in a Nevada court in December of this year. Additional bellwether trials are expected to begin in January 2013. According to the report, these cases are part of an estimated 2,000 DePuy hip lawsuits filed in state courts across the country. Several thousand more lawsuits are also pending in federal court after being consolidated into a multidistrict litigation (MDL) for pretrial proceedings. The plaintiffs involved in the DePuy hip litigation allege that they experienced pain, swelling, tissue damage, loss of mobility and other complications after being fitted with an ASR all-metal hip implant.  The lawsuits also allege that DePuy and Johnson & Johnson knew of potential problems with the metal hip replacement devices but did not take adequate steps to warn consumers of the dangers.

DePuy initiated a recall of approximately 93,000 ASR hips in August 2010 after data from joint registries in the U.K. and Australia indicated that the devices were failing at a much higher rate than initially expected. Specifically, failure rates appeared to hover between 12 and 13 percent within the first five years following hip replacement surgery.  Reports from the New York Times have suggested that Johnson & Johnson may have been aware of problems with the DePuy ASR hip for as long as a year before the recall was ever issued. It has also been suggested that the company continued to market an ASR hip resurfacing device overseas for as long as a year after the device was rejected by the U.S. Food and Drug Administration.

DePuy ASR hip lawsuits continue to mount, both in the U.S. and in countries around the world. Patients in the U.K., Australia and Ireland have reportedly taken steps to pursue legal action against Johnson & Johnson and DePuy in connection with the defective metal hips. Meanwhile, researchers have continued to evaluate the potential for additional health complications stemming from all-metal hip implants, including the potential for an increased cancer risk. While a recent study concluded that there was no definitive link between metal hip implants and cancer, the researchers did acknowledge that additional long-term studies are need to fully assess the risk

DePuy Hip Recall, DePuy Hip replacement Lawyers

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

It has been approximately 18 months since DePuy recalled two types of its ASR hip implants and The dePuy Hip replacement Helpline is still taking calls from people needing revision surgery from a failed DePuy.

18 Months After DePuy ASR Recall – Now What?
Jackie Fedeli

It has been approximately 18 months since DePuy recalled two types of its ASR hip implants.

What was Recalled and Why

The DePuy ASR ™ XL Acetabular System and the DePuy ASR ™Hip Resurfacing System were recalled amid safety concerns. The recall came after data from the U.K. indicated that 12% of patients who received the ASR ™ Resurfacing System needed revision surgery within five years of implant and that 13% of patients who received the ASR ™ replacement system needed revision surgery within five years of implant. These percentages are higher than revisions surgery rates for other types of hip implant devices.

What Patients with DePuy ASR Hip Systems Should Do Now

As DePuy ASR news continues to break, patients are urged to know their options for fixing a failed DePuy hip replacement. Surgery may be the only option available, though surgery is, of course, not without risks, pain and financial costs. For this reason, patients who received one of the recalled DePuy hip implant systems between July 2003 and August 2010 are encouraged to see their physicians for an evaluation and to learn more about the symptoms that may require prompt medical treatment.

Unfortunately, the 2010 DePuy ASR hip recall does not mean that patients are no longer at risk. Hip failures may still continue to occur and patients may still suffer

Growing Concern for Medical Device Safety

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Medical Device Safety Improvement Campaign
Tuesday, February 07, 2012 :: Staff infoZine
Consumer group teams up with patient safety activists to urge congress to strengthen medical device oversight

Washington, D.C. – infoZine – As the debate in Congress over reauthorizing the statute governing medical devices intensifies, Consumers Union is stepping up its campaign to strengthen the law to better protect patients from potential safety risks. This week, Consumers Union’s Safe Patient Project is bringing eight patient safety activists from around the country to Washington, D.C. to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act (MDUFA).

Consumers Union is urging Congress to require more rigorous testing before all medical implants are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems come to light. The campaign is up against a powerful lobbying effort by the medical device industry, which is using the MDUFA reauthorization process to try to scale back oversight by the Food and Drug Administration (FDA).
“Most Americans would be surprised to learn of the lax oversight of medical implants,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.”

Among those patient safety activists joining Consumers Union this week in Washington is Lana Keeton of Austin, Texas, who has endured ten years of incapacitating pain from the surgical mesh that was implanted during surgery for a prolapsed bladder. Steven Baker of Bloomington, Minnesota, who has suffered from a faulty elbow implant, will be meeting with lawmakers to urge Congress to adopt stricter medical device safety requirements. And Dan Walter, of Deale, Maryland, will share the story of his wife Pam, who nearly died from a defectively designed device used to treat her heart condition.
Unlike prescription drugs, more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale. According to the General Accounting Office, an average of 700 different medical devices are recalled each year. In 2009 alone, the FDA received reports of nearly 5,000 deaths associated with medical devices.

In addition, the system for monitoring and tracking what happens with devices once they are on the market is weak and does not adequately protect people using them. There is currently no national tracking system to identify and inform patients when safety problems emerge.
The FDA has just completed negotiations with the device industry over the shape of MDUFA reauthorization legislation that must be passed later this year. Industry pressure resulted in an agreement that does not include important safety provisions supported by Consumers Union, such as making sure faulty devices aren’t used to clear similar implants and giving the FDA the authority to require clinical trials after devices go onto market. Instead, the agreement focuses more on how the FDA can better serve the industry.

“The agreement is disappointing because it fails to include critical safety reforms needed to better protect patients and falls short of the resources the FDA needs to keep up with the volume and complexity of device applications,” said Lisa Swirsky, senior policy analyst for Consumers Union. “This year’s legislation will govern the safety and quality of medical devices over the next five years. Congress should strengthen the FDA’s ability to protect consumers.”

For more details on the reforms Consumers Union is urging Congress to adopt, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet link.

Cobalt Toxcity Found in Hip Replacement Patients, Anchorage Alaska

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Anchorage Fracture and Orthopedic Clinic.)
Cobalt Toxicity in Two Hip Replacement Patients
Introduction
Over the past decade, cobalt-chromium Metal-on-Metal Hip Arthroplasty (MoMHA) has been performed with increasing frequency throughout the United States, particularly in active and younger patients. During a recent review of the Nationwide Inpatient Sample database, 35% of 112,095 primary total hip replacements performed in the United States between October 1, 2005, and December 31, 2006 were MoMHAs.1 Cobalt and chromium ions are commonly detected in the blood and urine of MoMHA patients as a result of wear at the bearing surfaces over time. The accumulation of metal ions in the areas surrounding the prosthetic joint can cause metallosis, indicated by the formation of giant cells and fibrosis in surrounding tissue. Patients with malfunctioning MoMHAs can have Serum Cobalt Levels (SCoLs) that are more than 100-fold that of physiologic levels.2
An essential trace element, cobalt can cause serious adverse health effects at high exposure levels. Serum concentrations >1 mcg/L indicate possible environmental or occupational exposure, and concentrations >5 mcg/L are considered toxic.3
Signs and symptoms of cobalt poisoning can include visual impairment, cardiomyopathy, cognitive impairment, auditory impairment, hypothyroidism, peripheral neuropathy, and rashes.4 Three prior case reports note blindness, deafness, heart failure, peripheral neuropathy, rashes, and hypothyroidism in patients with SCoLs >200 mcg/L due to a malfunctioning MoMHA.5-7 This Bulletin describes two Alaska patients who experienced notable neurologic and cardiac symptoms following MoMHA.
Case Reports
Patient A, a fit, otherwise healthy, 49 year-old male received a MoMHA for osteoarthritis. An echocardiogram performed prior to his MoMHA showed normal myocardial function. At 3 months post-op, he complained of bilateral axillary rashes. At 8 months post-op, he reported unaccustomed shortness of breath. Pulmonary function tests and allergy testing for metals were normal. At 18 months post-op, he reported anxiety, headaches, irritability, tinnitus, and hearing loss. An audiogram confirmed high-frequency hearing loss. At 30 months post-op, he reported pain interrupting sleep, hip creaking, hand tremor, diminished coordination, slow cognition, poor memory, and lassitude. At 36 months post-op, a non-refractive loss of peripheral visual acuity was noted; at this time, his SCoL was 122 mcg/L.
The patient was indicated for revision surgery due to progressive hip pain and high SCoLs. An echocardiogram performed prior to the revision showed diastolic dysfunction. The revision was performed 43 months after the first surgery. At revision surgery, the periprosthetic tissues showed necrosis and staining with metal debris and visible wear of the retrieved bearing. At 1 month post-revision, Patient A’s SCoL was 14 mcg/L. At 6 months post-revision, he reported that all symptoms were improved except the visual changes.
Patient B, a fit, otherwise healthy, 49 year-old male received a MoMHA for a failed arthroplasty. At 12 months post-op, he complained of mental fog, memory loss, vertigo, hearing loss, groin pain, rashes, and breathlessness. At this time, his serum cobalt level was 23 mcg/L. At 18 months post-op, an echocardiogram showed diastolic dysfunction. He was observed until 40 months, when revision surgery was performed for progressive hip pain. Just before the revision, Patient B’s SCoL was 23 mcg/L. At revision surgery, the periprosthetic tissues showed necrosis and staining with metal debris and his retrieved bearing showed visible wear. At 2 days post-revision, his SCoL fell to 11 mcg/L. At 3 months post-revision, his symptoms were improved.
Discussion
MoMHA patients for whom revision surgeries are indicated due to pain often have implant malposition and periprosthetic metallosis. Additionally, these patients often have high SCoLs despite normal renal function and are at risk for cobalt poisoning. Patients with impaired renal function may experience cobalt poisoning without the presence of pain despite a well positioned implant because the cobalt released by normal implant wear is not adequately cleared by their kidneys.
In April 2010, the United Kingdom’s Medical Products and Healthcare Devices Regulatory Agency published a medical device alert that recommended following MoMHA patients for cobalt toxicity symptoms at least annually for 5 years post-op.8 The alert also recommended considering SCoL testing and imaging studies for patients who report painful hip replacements, and performing follow-up SCoL testing 3 months after the first test in patients with SCoLs >7 mcg/L in order to identify patients who require closer surveillance.
These two Alaska case reports underscore the importance of monitoring MoMHA patients for signs and symptoms of cobalt toxicity.9
Recommendations
1. Health care providers should be aware that patients with a MoMHA implant are at risk for cobalt poisoning, and might present for medical attention to non-orthopedists with cardiac or neurologic symptoms resulting from cobalt poisoning.
2. Health care providers should ask MoMHA patients who are known to have shell malposition, persistent or worsening hip/groin pain, and renal insufficiency about cardiac and neurologic symptoms, including tinnitus and hearing loss, and consider obtaining a SCoL.
3. Health care providers should assess cardiac and neurologic function in patients with SCoLs >7 mcg/L.
4. In consultation with the patient’s orthopedist, health care providers should develop an individualized plan for symptom monitoring and possible revision surgery in symptomatic patients with an elevated SCoL.
References
1. Bozic KJ, Kurtz S, Lau E, et al. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am 2009;91(7):1614-20.
2. Smet K, De Haan R, Calistri A, et al. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am 2008;90 Suppl 4:202-8.
3. Leavelle DE, Mayo Medical Laboratories. Mayo Medical Laboratories interpretive handbook: interpretive data for diagnostic laboratory tests. Rochester, Minn.: The Laboratories; 2001.
4. Smith IC, Carson BL. Volume 6-Cobalt An Appraisal of Environmental Exposure. 1st ed. Ann Arbor: Ann Arbor Science; 1981.
5. Oldenburg M, Wegner R, Baur X. Severe cobalt intoxication due to prosthesis wear in repeated total hip arthroplasty. J Arthroplasty 2009;24(5):825 e815-20.
6. Steens W, Loehr JF, von Foerster G, Katzer A. [Chronic cobalt poisoning in endoprosthetic replacement]. Orthopade 2006;35(8):860-4.
7. Rizzetti MC, Liberini P, Zarattini G, et al. Loss of sight and sound. Could it be the hip? Lancet 2009;373(9668):1052.
8. UK. Medicines and Healthcare Products Regulatory Agency; MDA/2010/033: All metal-on-metal hip replacements. Available at: http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157
9. ATSDR’s Toxicological Profile for Cobalt. Available at: http://www.atsdr.cdc.gov/toxprofiles/tp33-c3.pdf

DePuy hip recall lawyers are reviwewing cases nationwide for metal on metal hip implant metallosis or toxicity. call the Hip recall helpline for information.

DePuy Hip Replacement Helpline, Medical Social Worker Discusses

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Depuy Hip Replacement Helpline A Medical Social Workers Perspective a DePuy hip Replacement Helpline has been launched for Victims of the DePuy Hip Replacement. According to our Medical Social Worker, "the faulty hip replacements have a huge effect on our over 65 community”  See out article below.

 

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Apr 11, 2011 –   According to our research, these faulty hip replacements affect seniors at a time in their lives when quality of life and independence are crucial factors.

“Any surgery takes longer to recover from and having to go thru it twice is very difficult for our seniors” The psychological and physical effects put seniors back months”. Having to go through additional pain and surgeries can lead to severe depression and a downhill process” “People are now afraid to get hip replacements due to all the bad publicity. “This affects their independence and future health and mobility”

In the months since a recall of the DePuy ASR XL artificial hip, DePuy might be facing the recall of yet another one of its hip replacements, the Pinnacle Acetabular Component, which has been facing increased scrutiny for its premature failures.

Like the ASR XL, the Depuy Pinnacle is a metal on metal system that was designed to last at least 10-15 years but now, orthopedic surgeons are reporting that these devices have been failing within one to two years of being implanted into their patients.doctors in England are now reporting that 49 percent of DePuy ASR XL hip implants have failed after six years. This is a sharp increase in failures since seven months ago when DePuy recalled the hip implants because the failure rate was 12 percent

That’s not good news for DePuy, a division of Johnson & Johnson, which has implanted over 150,000 Pinnacle hip replacements into patients since it was put into service in 2001. Its recent recall of the defective ASR metal-on-metal hip implant systems has forced thousands of hip implant patients to have additional, painful and expensive hip revision surgeries. This effects seniors the most. All surgeries at that age are traumatic with extensive recovery time and rehabilitation. After the surgery, the patient, can spend weeks in a rehabilitation facility away from family, friends and routine.According to physiciansYou will be allowed only limited movement immediately after hip replacement surgery. When you are in bed, pillows or a special device are usually used to brace the hip in the correct position. You may receive fluids through an intravenous tube to replace fluids lost during surgery. There also may be a tube located near the incision to drain fluid, and a type of tube called a catheter may be used to drain urine until you are able to use the bathroom. The doctor will prescribe medicine for pain or discomfort.

 

On the day after surgery or sometimes on the day of surgery, therapists will teach you exercises to improve recovery. A respiratory therapist may ask you to breathe deeply, cough, or blow into a simple device that measures lung capacity. These exercises reduce the collection of fluid in the lungs after surgery.

 

As early as 1 to 2 days after surgery, you may be able to sit on the edge of the bed, stand, and even walk with assistance.

 

While you are still in the hospital, a physical therapist may teach you exercises such as contracting and relaxing certain muscles, which can strengthen the hip. Because the new, artificial hip has a more limited range of movement than a natural, healthy hip, the physical therapist also will teach you the proper techniques for simple activities of daily living, such as bending and sitting, to prevent injury to your new hip.

 

This isolation can effect mood. After discharge there is usually weeks of in home rehabilitation.Exercise becomes significantly more important as we age for strength and balance. These surgeries,with recuperation time, less weight bearing, and reliance on others effects individuals over the age of 65 much more then a younger ,more active person.Many people think that beyond a certain age, you become too weak to strength train or benefit from it. But research shows the complete opposite. Without adequate muscle exercise, most adults lose 20 to 40 percent of the muscle they had as young adults. With too much muscle loss people have difficulties performing daily activities that allow them to live independently. Usually, people do not spend more than 3 to 5 days in the hospital after hip replacement surgery. Full recovery from the surgery takes about 3 to 6 months, depending on your overall health, the age at which this occurs, and the success of your rehabilitation. Going through this once is traumatic, “We do not know how many seniors can actually go through this twice and regain the pre -surgery level of functioning”. We feel this will not only affect an individuals quality of life but perhaps even life span ,depending on age and other health factors. “If a senior has kept going, for instance, by play golf every day with friends and he or she loses this ,it could be a downhill road” You may contact the helpline by calling 1877-522-2123

Although the ASR and Pinnacle are both metal on metal systems, there are significant differences between the two insofar as:

* the ASR is a monoblock design whereas the Pinnacle uses a modular system.

* the ASR cup is made of one solid piece of metal whereas the Pinnacle has an outer shell

* The Pinnacle is designed in such a way that the surgeon has the option to place a metal, ceramic or polyethylene liner inside the metal outer cup

Much of the problem seems to be with the Pinnacle 36 mm Ultamet Metal-on-Metal component which is failing at an unacceptably high rate. One of the theories seeking to determine the cause suggests that a design problem flows from the fact that the device has been created with one of the lowest clearance levels in the industry. The only other implant with a clearance level this low is the DePuy ASR.

Attorneys and experts investigating the basis for the high rate of failure point to the product design and believe that DePuy created a very narrow window for proper placement of the prosthesis and inadequately trained surgeons in the proper implantation technique.

Like, the recalled DePuy ASR system, the Pinnacle was permitted to reach the market under the U.S. Food and Drug Administration’s (FDA) controversial 510(k) approval process, which allows a medical device to be placed on the market without being subjected to necessary clinical trials as long as the manufacturer can show that the device is “substantially equivalent” to a device already approved on the market. DePuy’s ASR system avoided obligatory clinical trials by showing that it was fundamentally similar to the DePuy Pinnacle hip replacement system, raising some serious issues.

Recently, the FDA has received hundreds of complaints and adverse incident reports against the Pinnacle system, attributed mostly to the Pinnacle’s propensity to prematurely separate from the bone. Moreover, like many other metal on metal devices, constant friction in the Pinnacle may cause an increased risk of metallosis, i.e. the release of miniscule metal particles into the surrounding soft tissue or bloodstream.

All of this has resulted in a wave of new lawsuits being filed around the country against DePuy. Just last week, a motion was filed in the United States District Court in California seeking to consolidate all DePuy Pinnacle cases before one judge in what is known as a multi- district litigation, or MDL. The MDL Panel is scheduled to rule on this application in May.

In the interim, the helpline and its hip replacement team continue to investigate claims of Pinnacle failures and counsel our clients on what to do in the event that they need revision surgery.

 

If you or a loved one have been implanted with a DePuy Pinnacle hip replacement and are experiencing any pain or disability:

-See a doctor immediately.

-Do not release any of your confidential medical information to any DePuy representatives before speaking to experienced hip replacement counsel.

-If you are told that you will need hip revision surgery, make sure that the removed component parts are preserved. Your counsel should be familiar with this process and be working with the proper experts to insure that it is done correctly.

We have huge concerns about the number of recalls and the new

replacements that keep getting added to the list” ”This effects our huge aging population. Individuals over the age of 60 and , more so ,70 are effected. individuals with numerous falls and hip fractures are candidates as well. This could effect a huge population by the time all the information comes out” ” From a social work perspective” — this is very serious.

 

What do you need to have to be part of the class action

 

  • Letter from your doctor or your surgeon with information about the original hip implant
  • A Hip implant ID card or the model number
  • Date and time of hip revision surgery and the Doctor who performed it
  • Records of the revision surgery and an accompanying surgeon’s report as to what was found
  • A preserved DePuy ASR hip implant that was removed after the surgery. Your hospital should have this
  • Records of all your doctors appointments and any related symptoms, such as pain, blood tests indicating metallic poisoning, difficulty walking, etc.
  • Records of lost time from work and wages lost, as well as records of any and all medical treatments, therapies, and home-visits related to the DePuy ASR hip problems

 

The DePuy Hip Replacement  Helpline assists individuals in getting a DePuy recall lawyer.

The DePuy Hip Replacement Helpline can be reached at 1 877 522 – 2123

 

 

You and Your Hip Implant, DePuy Hip Replacement Helpline

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

 

Questions and Answers About Metal-on-Metal Hip Implants
If your hip has been damaged by arthritis, a fracture, or other condition, common activities such as walking or getting in and out of a chair may be painful and difficult. You may be considering hip replacement surgery. By replacing your diseased hip joint with an artificial joint, hip replacement surgery can relieve your pain, increase motion, and help you get back to enjoying many normal, everyday activities.
How Your Hip Works
The hip is one of the body's largest weight-bearing joints. It is a ball-and-socket joint. The socket is formed by the acetabulum, which is part of the large pelvis bone. The ball is the femoral head, which is the upper end of the femur (thighbone). Bands of tissue called ligaments (hip capsule) connect the ball to the socket and provide stability to the joint.

 

 
 
 
 
 
 
Normal hip anatomy.
 
 
 

 
Hip Replacement Devices
After you and your orthopedic surgeon have determined you are a candidate for hip replacement surgery, your surgeon will select a hip replacement device for you based on your body structure, medical history, and lifestyle.
Many different types of designs and materials are currently used in artificial hip joints. All of them consist of two basic components: the ball component (made of a highly polished strong metal or ceramic material) and the socket component (a durable cup of plastic/polyethylene, ceramic, or metal). Sometimes, the socket is made of a different material than the ball, or is lined with a different material, and sometimes the ball and socket are made of the same material. Your orthopedic surgeon will recommend the best combination for you.

Implant Complications

All hip implant devices — no matter what type — can have complications. The most common complications include implant dislocation and device wear.
Bone loss, or osteolysis, is also a known complication. When the ball component moves against the cup, the surface begins to wear away and small debris particles are given off. The debris remains around the joint and over time can cause the bone around the implant to thin and weaken. As a result, the implant components can loosen and additional surgery may be necessary.
Researchers are continuing to study different device surfaces in order to address the problems of wear debris and osteolysis.
 
 
 

Metal-on-Metal (MoM) Devices

In metal-on-metal devices both the ball and socket components are made of metal. These metal implants have been used in total hip replacement surgeries and hip resurfacing procedures.
Because of metal's durability, metal-on-metal devices were expected to last longer than other hip implants. In addition, the ball in a metal-on-metal device is larger, making the hip joint more stable and less likely to dislocate.
MoM implants have also been used because they avoid the complication of debris wear from implants made of plastic/polyethylene. However, recent information about the wear of certain metal-on-metal devices has raised concerns about their use. Like polyethylene, metal surfaces give off small particles of debris. In addition, metal surfaces can corrode, giving off metal ions. Metal debris (ions and particles) can enter the space around the implant, as well as enter the bloodstream. This can cause a reaction in some patients, such as pain or swelling around the hip, osteolysis, and very rarely symptoms in other parts of the body.
Although the vast majority of patients have not had any problems with MoM implants, orthopedic surgeons and the U.S. Food and Drug Administration (FDA) are concerned because cases have been reported in the peer-reviewed literature and through a British database in which patients have local hip symptoms (pain and swelling). In addition, there have been a very small number of cases that have had other medical concerns seemingly unrelated to the hip.
 
 
 

Updates on Metal-on-Metal Devices from the FDA
In February 2011, the U.S. Food and Drug Administration (FDA) issued a public health communication about hip replacement components that have both a metal ball and a metal socket (metal-on-metal hip devices).
On May 6, 2011, the Food and Drug Administration (FDA) issued a post market surveillance study of total metal-on-metal hip replacement devices. Metal-on-metal (MoM) hip devices consist of a ball, stem, and shell, all made of metal parts. A post market surveillance study monitors adverse events after a device has been approved or cleared by the FDA. Manufacturers of metal-on-metal hip implants have orders from the FDA to further study the safety of metal-on-metal devices. As a result, if you have a metal-on-metal hip replacement device, your surgeon may be contacting you to find out how your device is functioning.
If after a joint replacement surgery you experience pain or have other, new medical concerns or issues, please talk to your doctor or orthopedic surgeon.
 
The Importance of Physician-Patient Communication
The American Academy of Orthopaedic Surgeons (AAOS) believes that physician and patient joint decision making leads to the best surgical outcomes. Share your concerns, voice your questions, and offer a complete medical history so that you and your surgeon can together develop the best plan for you.
There are many issues to discuss with your orthopaedic surgeon when you are considering total hip replacement surgery. It is helpful to make a list of the questions you would like to ask.
Your surgeon will also talk with you about hip implant devices. To help you with this discussion, here are examples of questions you may want to ask your surgeon:
  • What are your experiences with specific hip implant devices and how often do you use one over the other?
  • What are the risks and benefits of different devices (metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, and ceramic-on-ceramic devices)?
  • If applicable, what is the surgeon's personal experience and outcomes with metal-on-metal hip devices?
  • If your surgeon recommends a metal-on-metal device, ask why a metal-on-metal hip implant is the best for your situation.
  • DePuy and Johnson and Johnson Voluntarily recalled the DePuy due to the high failure rate.
 
Frequently Asked Questions About Metal-on-Metal Hip Implants

What kind of recovery should I expect after hip replacement surgery?

After undergoing hip replacement, you may expect your lifestyle to be a lot like the way it was before, but without the pain. In many ways, you are right, but it will take time. You need to be a partner in the healing process to ensure a successful outcome.
 
 
 

What personal health information should I share with my orthopedic surgeon if I am considering a metal-on-metal hip implant?

It is critical that your orthopedic surgeon know your complete medical history including any problems you may have with your kidneys and any known sensitivities or allergies to metal — for example, if you have allergic reactions from wearing certain jewelry.
 
 
 

Is there a way to determine ahead of time if I might have a reaction to the metal in the metal-on-metal hip implant system?

Currently there is no widely accepted test to predict if you will develop a reaction to the metal from a hip system, and there is insufficient evidence to support using a skin patch test to determine your sensitivity to a metal-on-metal hip implant. If, however, you have a known sensitivity to metal, it is important to share that information with your surgeon.
 
 
 

Are there any ways to prevent the metal from reaching the joint and bloodstream if I get a metal-on-metal hip implant?

No. All artificial hips require one component to slide against another component and it is inevitable that material at the surfaces will wear as they interact. In metal-on-metal hip implants, some tiny metal particles and metal ions are released into the joint space and metal ions can potentially enter the bloodstream. Certain characteristics may place patients at risk for increased wear and metal ion production, and these patients will need closer follow-up after implantation. However, how a patient reacts to the metal is variable.
 
 
 

Which patients should not have a metal-on-metal hip implant system implanted?

Each type of hip implant system has its own set of benefits and risks. Metal-on-metal hip implant systems are not for everyone. You should discuss your situation with your orthopadic surgeon to determine whether you are a candidate or not. In general, metal-on-metal hip systems are not meant to be implanted in patients:
  • Who have kidney problems
  • Who have a known allergy or sensitivity to metals
  • Who have a suppressed immune system
  • Who are currently receiving high doses of corticosteroids such as prednisone
  • Who are women of childbearing age
In addition, people with smaller body frames may be at increased risk for adverse events and device failure.
 
 
 

Why are women of child-bearing age not good candidates for metal-on-metal hip implants?

As discussed above, recent information shows that metal ions can leave the artificial joint and enter the bloodstream. It is not known how long they remain in blood or other organs of the body.
Some metallic ions may cross the barrier from mother to fetus through the placenta. It is not known if the amount of ions is great enough to have any effect on the growing fetus or if the presence of metal ions in the mother's bloodstream will have any effect on future pregnancies.
For this reason, it is recommended that younger women who need hip replacement surgery consider implant options other than metal-on-metal.
 
 
 

With the risk of adverse reactions to metal-on-metal hip implant systems, why are these devices still being offered to patients?

It is known that every different type of hip implant system has its own set of risks as well as its own set of benefits. FDA's assessment of medical devices such as metal-on-metal (MoM) hip implants is based on a risk-benefit ratio with the data available. MoM hip implants overall have been shown to provide significant benefits  in certain patient populations. Although the exact prevalence of adverse reactions to metal debris is not known, current experience leads us to consider the adverse outcomes to be relatively low or equal (with some designs) to other types of hip implants. Thus, for many patients, currently available information supports a favorable risk-benefit ratio.
The orthopaedic surgeon should assess the patient's individual needs and should avoid using metal-on-metal hip implants in patients where the risks outweigh the benefits.
 
 
 

 
Information for Patients Who Have Metal-on-Metal Hip Implants

How do I know if I have a metal-on-metal hip system?

Patients are usually told about the type of implant they are receiving prior to the surgery. If you are uncertain about which type you have, you should contact the orthopedic surgeon who performed your procedure.
 
 
 

How often should I follow-up with my orthopedic surgeon?

Based on your individual circumstances, your orthopedic surgeon will determine how frequently you need to follow-up. There are some cases where your orthopedic surgeon may recommend more frequent follow-up based on the type of hip implant, the outcome of the surgery and your recovery, and the results of blood tests or imaging procedures.
If you develop new or significantly worsening symptoms or problems with your hip, including pain, swelling, numbness and/or a change in ability to walk, contact your orthopaedic surgeon right away.
 
 
 

What should I discuss with my orthopedic surgeon at each follow-up appointment?

It is critical that you talk to your surgeon about any new or worsening symptoms related to your hip, groin, or legs since your last visit. This may include pain, swelling, numbness, and change in ability to walk. It is also important that you discuss:
  • Changes in your general health
  • Whether you are being seen or treated by another physician for a new condition since receiving your metal-on-metal hip implant

What symptoms might a metal-on-metal hip implant cause?

Symptoms may include hip/groin pain, local swelling, numbness or changes in your ability to walk. There are many reasons a patient with a metal-on-metal hip implant may experience such symptoms and it is important that you contact your surgeon to help determine why you are having them.
 
 
 

Are there other medical effects that can occur with my metal-on-metal hip implant system?

Metal-on-metal hip implants, like other types of hip implants, are known to have adverse events, including infection and joint dislocation. There are some case reports of the metal particles causing a reaction around the joint, leading to deterioration of the tissue around the joint, loosening of the implant, and failure of the device, as well as some of the symptoms described above. In addition, some metal ions from the implant may enter into the bloodstream. There have been a few recent case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart, and thyroid gland.
 
 
 

What are my chances of developing a reaction to my metal-on-metal hip implant and having these types of medical problems?

Although current data suggests that these events are rare, it is currently unknown how often they occur in patients with metal-on-metal hip implants.
Part of the difficulty in answering this question is that individuals vary in how they react to metal ions in their bodies. For example, a reaction may develop in Patient A in response to a very small amount of metal, whereas Patient B may be able to tolerate a much larger amount before a reaction develops.
 
 
 

If I you are experiencing adverse complications  associated  from your Hip Implant contact your orthopedic surgeon Immediately.

  1. If you are experiencing hip/groin pain, difficulty walking or a worsening of your previous symptoms, you should make an appointment to see your orthopedic surgeon for further evaluation of your implant. Your orthopedic surgeon may wish to perform a physical exam and an evaluation based on your symptoms.
  2. If you experience any new symptoms or medical conditions in your body other than at your hip, you should report these to your primary physician and remind them that you have a metal-on-metal hip implant system during their evaluation.

What should I do if I am not experiencing adverse events associated with my metal-on-metal hip implant?

If you are not having any symptoms and your orthopedic surgeon believes the metal-on-metal hip implant is functioning appropriately, there are no data to support the need for additional tests. You should continue to follow-up with your orthopedic surgeon for periodic examinations. Lawyers are accepting cases for the Depuy metal on Metal Hip Implants.
 
 
 

What should I discuss with my other healthcare providers including my general internist or family practice doctor?

There are rare case reports of patients with metal-on-metal hip implants who experienced medical problems in areas of the body away from their hip implant. This may have resulted from the metal ions released by the metal-on-metal hip implant.
If you see a healthcare provider for the evaluation of any new or worsening symptoms outside the hip/groin area, including symptoms related to your heart, nervous system, or thyroid gland, it is important that you tell that clinician of your metal-on-metal hip implant. This information may affect the types of tests that are ordered to further evaluate the cause of your symptoms.
 
 
 

When would a hip revision surgery be needed?

There are multiple reasons why a surgeon may recommend a device revision (a surgical procedure where your implant is removed and another put in its place). Many of these reasons, including infection, dislocation, and device fracture, apply to any type of hip implant. Your surgeon might also consider revision if you develop evidence of local or systemic reactions to the metal from your hip implant. In that case, the surgeon will take several factors into account in considering if and when a revision surgery is advisable.
 
 
 

What are the risks of revision surgery?

Any surgical procedure, including revision surgery, has risks associated with it, including reaction to the anesthesia, infection, bleeding, and blood clots. The revision surgery may be more difficult if you had a local reaction to the implant that may have affected your soft tissue and/or bone quality.
 
 
 

What does it mean when I see that a hip implant system has been "recalled?"

A hip system may be recalled by the manufacturer for a number of reasons. If your device is recalled, this does not necessarily mean that the device needs to be removed and replaced. In some cases, the recall just calls for different or more frequent monitoring. It is important to discuss the reason for the recall with your surgeon to determine the most appropriate course of action. If you are unsure if your hip implant was recalled, consult with your orthopaedic surgeon. Additional information on the recall can be obtained from the manufacturer or from the FDA
 
 
 

Where can I get additional information regarding metal-on-metal hip systems?

 
Source: This article includes information from the U.S. Food and Drug Administration communications regarding metal-on-metal hip implant systems.
 
 
 

 
 
AAOS does not endorse any treatments, procedures, products, or physicians referenced herein. Contact  Injury Lawyers Network Lawyers for the Metal on metal Hip Replacement. They are accepting cases for injured patients with failed implants.
 
 

 

 
 
 
 
 
 
 
 
Hip Replacement Devices
After you and your orthopaedic surgeon have determined you are a candidate for hip replacement surgery, your surgeon will select a hip replacement device for you based on your body structure, medical history, and lifestyle.
Many different types of designs and materials are currently used in artificial hip joints. All of them consist of two basic components: the ball component (made of a highly polished strong metal or ceramic material) and the socket component (a durable cup of plastic/polyethylene, ceramic, or metal). Sometimes, the socket is made of a different material than the ball, or is lined with a different material, and sometimes the ball and socket are made of the same material. Your orthopedic surgeon will recommend the best combination for you.

Implant Complications

All hip implant devices can have complications. The most common complications include implant dislocation and device wear. DePuy has been voluntarily recalled by Johnson and Johnson due to the high rate of failure and complications.
Bone loss, or osteolysis, is also a known complication. When the ball component moves against the cup, the surface begins to wear away and small debris particles are given off. The debris remains around the joint and over time can cause the bone around the implant to thin and weaken. As a result, the implant components can loosen and additional surgery may be necessary.
Researchers are continuing to study different device surfaces in order to address the problems of wear debris and osteolysis.

Metal-on-Metal (MoM) Devices

In metal-on-metal devices both the ball and socket components are made of metal. These metal implants have been used in total hip replacement surgeries and hip resurfacing procedures.
Because of metal's durability, metal-on-metal devices were expected to last longer than other hip implants. In addition, the ball in a metal-on-metal device is larger, making the hip joint more stable and less likely to dislocate.
MoM implants have also been used because they avoid the complication of debris wear from implants made of plastic/polyethylene. However, recent information about the wear of certain metal-on-metal devices has raised concerns about their use. Like polyethylene, metal surfaces give off small particles of debris. In addition, metal surfaces can corrode, giving off metal ions. Metal debris (ions and particles) can enter the space around the implant, as well as enter the bloodstream. This can cause a reaction in some patients, such as pain or swelling around the hip, osteolysis, and very rarely symptoms in other parts of the body.
Although the vast majority of patients have not had any problems with MoM implants, orthopedic surgeons and the U.S. Food and Drug Administration (FDA) are concerned because cases have been reported in the peer-reviewed literature and through a British database in which patients have local hip symptoms (pain and swelling). In addition, there have been a very small number of cases that have had other medical concerns seemingly unrelated to the hip.
Updates on DePuy Metal-on-Metal Devices from the FDA
In February 2011, the U.S. Food and Drug Administration (FDA) issued a public health communication about hip replacement components that have both a metal ball and a metal socket (metal-on-metal hip devices).
On May 6, 2011, the Food and Drug Administration (FDA) issued a post market surveillance study of total metal-on-metal hip replacement devices. Metal-on-metal (MoM) hip devices consist of a ball, stem, and shell, all made of metal parts. A post market surveillance study monitors adverse events after a device has been approved or cleared by the FDA. Manufacturers of metal-on-metal hip implants have orders from the FDA to further study the safety of metal-on-metal devices. As a result, if you have a metal-on-metal hip replacement device, your surgeon may be contacting you to find out how your device is functioning.
If after a joint replacement surgery you experience pain or have other, new medical concerns or issues, please talk to your doctor or orthopedic surgeon.
 
The Importance of Physician-Patient Communication regarding your Hip implant
The American Academy of Orthopedic Surgeons (AAOS) believes that physician and patient joint decision making leads to the best surgical outcomes. Share your concerns, voice your questions, and offer a complete medical history so that you and your surgeon can together develop the best plan for you.
There are many issues to discuss with your orthopedic surgeon when you are considering total hip replacement surgery. It is helpful to make a list of the questions you would like to ask.
Your surgeon will also talk with you about hip implant devices. To help you with this discussion, here are examples of questions you may want to ask your surgeon:
  • What are your experiences with specific hip implant devices and how often do you use one over the other?
  • What are the risks and benefits of different devices (metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, and ceramic-on-ceramic devices)?
  • If applicable, what is the surgeon's personal experience and outcomes with metal-on-metal hip devices?
  • If your surgeon recommends a metal-on-metal device, ask why a metal-on-metal hip implant is the best for your situation.
 
Frequently Asked Questions About Metal-on-Metal Hip Implants

What kind of recovery should I expect after hip replacement surgery?

After undergoing hip replacement, you may expect your lifestyle to be a lot like the way it was before, but without the pain. In many ways, you are right, but it will take time. You need to be a partner in the healing process to ensure a successful outcome.

What personal health information should I share with my orthopedic surgeon if I am considering a metal-on-metal hip implant?

It is critical that your orthopedic surgeon know your complete medical history including any problems you may have with your kidneys and any known sensitivities or allergies to metal — for example, if you have allergic reactions from wearing certain jewelry.

Is there a way to determine ahead of time if I might have a reaction to the metal in the metal-on-metal hip implant system?

Currently there is no widely accepted test to predict if you will develop a reaction to the metal from a hip system, and there is insufficient evidence to support using a skin patch test to determine your sensitivity to a metal-on-metal hip implant. If, however, you have a known sensitivity to metal, it is important to share that information with your surgeon.

Are there any ways to prevent the metal from reaching the joint and bloodstream if I get a metal-on-metal hip implant?

No. All artificial hips require one component to slide against another component and it is inevitable that material at the surfaces will wear as they interact. In metal-on-metal hip implants, some tiny metal particles and metal ions are released into the joint space and metal ions can potentially enter the bloodstream. Certain characteristics may place patients at risk for increased wear and metal ion production, and these patients will need closer follow-up after implantation. However, how a patient reacts to the metal is variable.

Which patients should not have a metal-on-metal hip implant system implanted?

Each type of hip implant system has its own set of benefits and risks. Metal-on-metal hip implant systems are not for everyone. You should discuss your situation with your orthopedic surgeon to determine whether you are a candidate or not. In general, metal-on-metal hip systems are not meant to be implanted in patients:
  • Who have kidney problems
  • Who have a known allergy or sensitivity to metals
  • Who have a suppressed immune system
  • Who are currently receiving high doses of corticosteroids such as prednisone
  • Who are women of childbearing age
it appears, people with smaller body frames may be at increased risk for adverse events and device failure. This would effect women and children.

Why are women of child-bearing age not good candidates for metal-on-metal hip implants?

As discussed above, recent information shows that metal ions can leave the artificial joint and enter the bloodstream. It is not known how long they remain in blood or other organs of the body.
Some metallic ions may cross the barrier from mother to fetus through the placenta. It is not known if the amount of ions is great enough to have any effect on the growing fetus or if the presence of metal ions in the mother's bloodstream will have any effect on future pregnancies.
For this reason, it is recommended that younger women who need hip replacement surgery consider implant options other than metal-on-metal.

With the risk of adverse reactions to metal-on-metal hip implant systems, why are these devices still being offered to patients?

It is known that every different type of hip implant system has its own set of risks as well as its own set of benefits. FDA's assessment of medical devices such as metal-on-metal (MoM) hip implants is based on a risk-benefit ratio with the data available. MoM hip implants overall have been shown to provide significant benefits (e.g., high survivorship) in certain patient populations. Although the exact prevalence of adverse reactions to metal debris is not known, current experience leads us to consider the adverse outcomes to be relatively low or equal (with some designs) to other types of hip implants. Thus, for many patients, currently available information supports a favorable risk-benefit ratio.
The orthopaedic surgeon should assess the patient's individual needs and should avoid using metal-on-metal hip implants in patients where the risks outweigh the benefits.
 
Information for Patients Who Have Metal-on-Metal Hip Implants

How do I know if I have a DePuy metal-on-metal hip system?

Patients are usually told about the type of implant they are receiving prior to the surgery. If you are uncertain about which type you have, you should contact the orthopedic surgeon who performed your procedure.

How often should I follow-up with my orthopedic surgeon?

Based on your individual circumstances, your orthopedic surgeon will determine how frequently you need to follow-up. There are some cases where your orthopedic surgeon may recommend more frequent follow-up based on the type of hip implant, the outcome of the surgery and your recovery, and the results of blood tests or imaging procedures.
If you develop new or significantly worsening symptoms or problems with your hip, including pain, swelling, numbness and/or a change in ability to walk, contact your orthopedic surgeon right away. You must see your surgeon immediately if you notice anything unusual.

Discuss any complications orthopedic surgeon  immediately

It is critical that you talk to your surgeon about any new or worsening symptoms related to your hip, groin, or legs since your last visit. This may include pain, swelling, numbness, and change in ability to walk. You may experience a  grinding or popping noise.
  • Changes in your general health
  • Whether you are being seen or treated by another physician for a new condition since receiving your metal-on-metal hip implant

What symptoms and complications does a metal-on-metal hip implant cause?

Symptoms may include hip/groin pain, local swelling, numbness or changes in your ability to walk. There are many reasons a patient with a metal-on-metal hip implant may experience such symptoms and it is important that you contact your surgeon to help determine why you are having them.

Are there other medical effects that can occur with my metal-on-metal hip implant system?

Metal-on-metal hip implants, like other types of hip implants, are known to have adverse events, including infection and joint dislocation. There are some case reports of the metal particles causing a reaction around the joint, leading to deterioration of the tissue around the joint, loosening of the implant, and failure of the device, as well as some of the symptoms described above. In addition, some metal ions from the implant may enter into the bloodstream. There have been a few recent case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart, and thyroid gland.

What are my chances of developing a reaction to my metal-on-metal hip implant and having these types of medical problems? You should be evaluated for blood levels of Chromium and Cobalt.

Although current data suggests that these events are rare, it is currently unknown how often they occur in patients with metal-on-metal hip implants.
Part of the difficulty in answering this question is that individuals vary in how they react to metal ions in their bodies. For example, a reaction may develop in Patient A in response to a very small amount of metal, whereas Patient B may be able to tolerate a much larger amount before a reaction develops.

What should I do if I am experiencing adverse events associated with my metal-on-metal hip implant?

  1. If you are experiencing hip/groin pain, difficulty walking or a worsening of your previous symptoms, you should make an appointment to see your orthopaedic surgeon for further evaluation of your implant. Your orthopaedic surgeon may wish to perform a physical exam and an evaluation based on your symptoms.
  2. If you experience any new symptoms or medical conditions in your body other than at your hip, you should report these to your primary physician and remind them that you have a metal-on-metal hip implant system during their evaluation.

What should I do if I am not experiencing adverse complications with my metal-on-metal hip DePuy Hip implant?

If you are not having any symptoms and your orthopaedic surgeon believes the metal-on-metal hip implant is functioning appropriately, there are no data to support the need for additional tests. You should continue to follow-up with your orthopaedic surgeon for periodic examinations.

What should I discuss with my other healthcare providers including my general internist or family practice doctor?

There are rare case reports of patients with metal-on-metal hip implants who experienced medical problems in areas of the body away from their hip implant. This may have resulted from the metal ions released by the metal-on-metal hip implant.
If you see a healthcare provider for the evaluation of any new or worsening symptoms outside the hip/groin area, including symptoms related to your heart, nervous system, or thyroid gland, it is important that you tell that clinician of your metal-on-metal hip implant. This information may affect the types of tests that are ordered to further evaluate the cause of your symptoms.

Revision Surgery

There are multiple reasons why a surgeon may recommend a device revision (a surgical procedure where your implant is removed and another put in its place). Many of these reasons, including infection, dislocation, and device fracture, apply to any type of hip implant. Your surgeon might also consider revision if you develop evidence of local or systemic reactions to the metal from your hip implant. In that case, the surgeon will take several factors into account in considering if and when a revision surgery is advisable.

What are the risks of revision surgery?

Any surgical procedure, including revision surgery, has risks associated with it, including reaction to the anesthesia, infection, bleeding, and blood clots. The revision surgery may be more difficult if you had a local reaction to the implant that may have affected your soft tissue and/or bone quality. The DePuy has needed an unusually high number of revision surgeries.

What does it mean when I see that a hip implant system has been "recalled?"

A hip system may be recalled by the manufacturer for a number of reasons. If your device is recalled, this does not necessarily mean that the device needs to be removed and replaced. You shopuld contact your physician if you are experiencing complications and to discuss revision surgery.  You should discuss  your complications with your surgeon to determine the most appropriate course of action. If you are unsure if your hip implant was recalled, consult with your orthopedic surgeon. Additional information on the recall can be obtained from the manufacturer or from the FDA. The DePuy Hip Replacement was recalled by Johnson and Johnson in August of 2010.

Where can I get additional information regarding metal-on-metal hip systems?

 
Source: This article includes information from the U.S. Food and Drug Administration communications regarding metal-on-metal hip implant systems.
 
 

AAOS does not endorse any treatments, procedures, products, or physicians referenced herein.  DePuy Hip Replacement Helpline Lawyers are accepting clients with complications from the Metal on Metal DePuy  Hip Replacements.

Depuy Hip Replacement Recall Guide

Written by lisaspitzer on . Posted in Depuy Hip Replacement Blog

Depuy Hip Replacement Recall Guide, Depuy Hip Replacement Helpline

ASR Hip Replacement Recall Guide

 

 Depuy Hip Replacement Helpline Lawyers are acepting cases for failed Depuy Hip Replacements.

Professionals recall guide is a good resource to find out about your DePuy Hip recall.

The guide for healthcare professionals offers clinical detail about the ASR recall and provides help for answering patients’ questions.

Callers should dial the toll-free number 888-627-2677. The call center will be active from 8 a.m. to 9 p.m. EST, Monday through Saturday. for the DePuy manufacturers recall Information line.

DePuy ASR™ Hip Implant Recall Guide
guide for patients
The patient guide helps patients determine if they’re affected

Patient hip recall information

DePuy Orthopaedics has issued a voluntary hip implant recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System.
Your patients will have questions about the DePuy recall, and our goal with this guide is to help you answer their questions and to support your evaluation and continued care of them.

Broadspire Fact Sheet
ASR™ Hip System Patient Management Webcast
ASR Recall Update: Court Order on Explants
November 18, 2010 Optimized MRI Webcast

Patients who had hip surgery prior to July 2003 are not subject to this recall.

    reason for recall
    detailed information
    revision notification form

call for assistance
The following physicians are available for questions:
Rodrigo Diaz, Scientific Information Officer:
1-574-372-7401
Mikhail Chkolnik, Clinical Research Project Leader:
1-888-554-2482
DePuy Recall Information

DePuy makes patient safety and health a top priority and is continually evaluating data about its products, including the ASR Hip Systems. Most DePuy ASR hip replacement surgeries have been successful. However, In August 2010, DePuy received new, then-unpublished data from the National Joint Registry (NJR) of England and Wales showing that the five year revision rate for the ASR™ Hip Resurfacing System is approximately 12 percent. For the ASR™ XL Acetabular System, it is approximately 13 percent. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients. Because the new NJR data shows a higher than expected revision rate at five years, DePuy has issued a voluntary recall of all ASR products. Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the ASR™ XL Acetabular System was available worldwide. We appreciate your assistance in providing ASR hip implant recipients and your organization with important information about this recall.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Call the ASR help line

Callers should dial the toll-free number 888-627-2677. The call center will be active from 8 a.m. to 9 p.m. EST, Monday through Saturday.

 

 

 

 

 

 

 

 

 

To ASR Hip Replacement Patients:

 

At DePuy, our mission for more than a century has been developing products and technologies that help patients who have been impacted by pain, disability and a loss of mobility return to a more active lifestyle. If DePuy finds that one of its products is not meeting the high standards of our company, our patients, or our surgeons’, we take appropriate action. In August 2010, DePuy issued a voluntary recall of our ASR™ Hip System after receiving new, then-unpublished data from a joint replacement registry in the UK. This data indicated that while the vast majority of patients with the ASR Hip System were not experiencing any problems, a higher number of ASR patients than previously reported to DePuy needed a second surgery, called a revision surgery, earlier than expected.

 

It is important for all ASR patients to have their hip evaluated by their doctor, though most patients will not need additional surgery as a result of this recall.

 

Your safety and health are important to DePuy, and we are committed to providing ASR patients with the information and support they need for their recall-related medical care. DePuy is working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs.

 

There are many different brands of hip implants available, including several brands from DePuy Orthopaedics, and patients may not be aware of what brand of implant they have. We encourage patients to check with their surgeon or hospital to determine what brand of hip implant they have received.

 

If you have an ASR Hip, please call our ASR Help Line at 1-888-627-2677 to have your specific questions answered and to begin the claims and reimbursement process. We know that the recall is concerning to patients and their families. With this website, we have aimed to provide detailed information about the recall and what it means for you. The U.S. FDA also recently provided information on metal-on-metal hips, such as the ASR Hip System, which can be found here

 

If you have additional questions, please do not hesitate to call our ASR Help Line at 1-888-627-2677.

 

Sincerely,

DePuy Orthopaedics

 

Attorneys at Injury Lawyer Network are accepting clients with complications from a failed Deuy Hip Replacement

 

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