• Vena Cava IVC Filter Lawyers- IVC Filter Helpline:   Bard and Cook IVC Filter Lawyers Lawsuits are being filed  because the IVC (Inferior Vena Cava) Filters have been linked to migration and perforation of various organs in the body. An IVC (In...

  • Omni Life Hip Apex Arc Replacement Lawyers: Omni Life Apex ARC Hip Replacement Lawyers OMNI Life Science’s ARC hip Replacement has a  chromium and cobalt ball connecting to a titanium stem, is a metal-on-metal design. This hip replacement is l...

Posts Tagged ‘Metal on metal hip replacements’

Seniors and Athletes are Prone to Hip Fracture and Victims of the DePuy Hip Replacement recall

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Now that the dePuy Hip Replacement is going to trial we can take a look at who is most likely to be a victim of a failed DePuy. Well, it is most likely someone prone to Hip fractures whic eventually result in needing a hip replacement. DePuy Hip replacement helpline is reaching out to seniors and athletes as the time is running short. Each state has a statute of limitations and that is usually going to block your ability to file. You must act quickly.

Everyone is at risk of incurring fractures. On the other hand, people suffer increased risks with conditions like old age, osteoporosis, osteomyelitis, type two diabetes patients and other diseases that make the bone porous, brittle and highly permeable. Unfortunately, falls and hip injuries are common on frail elderly patients, making hip fracture rehabilitation a primary concern. Elderly and other people like athletes and workers who are prone or highly likely to incur hip injuries must establish an ongoing communication with a qualified medical doctor or orthopedic surgeon.

Types and Modes of Fractures that maybe  eventually requiring a hip replacement

There are several types of fractures, which doctors consider before diagnosis is set:

* Comminuted fracture – is the condition where the bones fragment into several pieces. * Oblique fracture – the bone breaks acquired a curved or sloping pattern. * Impacted fracture – otherwise known as the buckle fracture, this is the type of fracture whose ends are driven into each other. * Transverse fracture – the type of fracture forming a right angle to the bone’s axis. * Greenstick fracture – occurs when the bone is just bent and not fully broken. * Other types of fracture include pathologic, compressed, avulsion, depressed, and spiral.

Modes of Hip Fractures

Only a few types of fractures are associated with hip injuries, which cause back pain. With that, several modes of hip fractures and considered to thoroughly evaluate the extent of injury:

* Intertrochanteric hip fracture is the type of fracture that doesn’t involve or cause damage to the blood flow in the bone. It usually doesn’t require   hip replacement for treatment. * Intracapsular hip fracture is the type of bone breakage that occurs within the capsule of the joint. * Extracapsular hip fracture is the type of fracture that occurs at the articular extremity of the bone, which is outside the line of the attachment of the capsular ligament of the hip joint

Causes of Fractures

Bone fracture can happen to anyone. It’s typically caused by various types of trauma on the bone. Bone trauma may result from accidental falls, motor vehicle accidents or a disease that weakens the bone. Hence, hip and back injury, bone fracture may cause back pain, swelling, bruising and internal bleeding.

Assessment of Fracture Risks and Fracture Damage

The risks of getting fractures can be assessed by performing tests and evaluations on bone density, current medications taken, medical conditions, medical history or personal history, and lifestyle or work factors.

To assess actual fractures, doctors usually perform hematology tests and x-rays to evaluate and locate the fracture area. X-ray results will guide them in locating the breaks on the bones while hematology tests help them spot the decreases in HCT and Hgb, which indicative the severity of damage incurred. Doctors may assess the condition by evaluating the pain experienced from motion and the tenderness, immobility, deformity, crepitus, ecchymosis, edema and paresthesia or creeping, tingling and pricking sensations observed and experienced on the affected site

If you are an athlete who has had a Depuy hip replacement and has undergone revision surgery call the dePuy Hip Replacement Helpline today. If you are a senior or child of a senior who has had hip replacement surgery and it has been with one on the metal on metal recalls contact us immediately.

Metal on Metal Hip Replacement Toxicity, Hip Recall Lawyers Accepting Clients

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

Fears of faulty 'toxic' hip replacement implant

Mon, 30 Jan 2012 12:33:00 EST

Today many newspapers and TV stations have reported that medical regulators have launched an investigation into a type of hip replacement called a “metal-on-metal” (MoM) device (DePuy ASR hip replacement implant). The concern is that as the hip replacements wear down, metal particles can be released from the artificial hip, react with the soft tissue (such as muscle and ligaments) surrounding the joint and enter the bloodstream. In 2010, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a product recall for DePuy ASR, a brand of MoM artificial hip. This meant that surgeons were told not to implant DePuy ASR hip replacements and return any unused implants to the manufacturer.

The MHRA has urged surgeons to tell all patients that had received these DePuy ASR hip replacements about the recall, and to schedule them for annual follow-up visits. If the person who had a DePuy ASR hip replacement implant experiences pain, the surgeons should consider measuring the level of metals in their blood measured and should examine the soft tissue to see if reactions have occurred. If necessary, removal and replacement of the implant should be considered.

The Sunday Telegraph has brought this story to the public attention again because of what it says are subsequent developments. The Telegraph claims that the risk from the devices is greater than previously thought, with greater failure rates. The Telegraph says that the MHRA is drawing up a new alert for anyone with any type of metal-on-metal hip replacement. Channel 4 News reported that around 30,000 people in Britain have received MoM hip replacements, and that the MHRA has said that, on the evidence currently available, “the majority of people with metal on metal hip replacements are at low risk of developing any serious problems”. A spokesman for the MHRA is quoted as saying: “We are continuing to closely monitor all evidence. This needs more analysis before any conclusions can be drawn and further advice given”.

Medical devices, like medicines are regulated but are coming under more scrutiny, from both the regulators and the media following widespread concerns over the emergence of faults with illegally made PIP breast implants. Find out the latest NHS information on PIP breast implants.

What types of hip replacements are there?

In the UK, approximately 70,000 hip replacements are performed each year. In a total hip replacement operation an artificial ball is attached to the top of the leg bone and an artificial socket is attached to the hip bone. The socket can be made out of plastic or ceramic, while the ball is metal. The ball is attached to a shaft, which is placed in the hollow of the leg bone (femur). Some people do not need a total hip replacement, but have a hip resurfacing operation. This has the advantage of removing less of the person’s own bone. The joint surfaces are replaced with metal inserts that cover the surfaces of the hip but do not extend down the inside or hollow of the leg bone. The metal mixtures used in hip replacements contain the metals chromium and cobalt.

What are the risks of problems following a metal-on-metal hip replacement?

When hip resurfacing was initially introduced, metal-on-metal (MoM) replacements were popular, especially with younger, active patients. An article by two orthopaedic surgeons working in Britain and published in the British Medical Journal in 2011 said that they were used in 10% of hip operations between 2006 and 2009, and 50% of all hip replacements in people younger than 50 years. However, problems with the metal resurfacing included raised chromium and cobalt in the blood, loosening of the joint, hip fracture and soft tissue reactions around the hip. It reported that problems with metal on metal hip replacements could include reactions to metal debris and associated pain, swelling, loss of movement and limping.

In March 2011, delegates at the British Hip Society annual conference discussed MoM hip replacements. Units in Belfast, Southampton, Cardiff and Stockton-on-Tees that had researched the outcomes for people who had these devices fitted over the short- to mid-term, said that a high proportion of MoM devices from other manufacturers may also be showing similar results to the withdrawn DePuy device. They found that, overall, the MoM devices showed a higher than anticipated early failure rate (most hip replacements last about 20-30 years). They found that 49% of people who had been fitted with the DePuy device needed it to be replaced by six years and between 12 and 15% who had other metal-on-metal hip replacements needed these to be replaced by five years. They said that the patients whose replacements failed tended to come to the doctors when they experienced pain. X-rays showed some patients had loosening of the joint, and some patients had raised levels of cobalt and chromium in their blood.

The inclusion of the word “poisoned” in some newspapers is likely to be wrong. Metal from the hip replacements can enter the bloodstream, but the levels of cobalt and chromium found give an indication of the wear to the hip replacement. No evidence for damage other than local tissue damage was presented. The MHRA’s advice is to monitor the level of chromium and cobalt to see if a patient requires further follow-up.

What is the advice for people who have had a MoM hip replacement?

The MHRA has not issued new guidance as yet. However, the report from the British Hip Society annual conference says that they believe that the existing advice from the MHRA still applies. This means that people who have been treated with a MoM hip replacement should be followed up regularly for five years and probably for the life of the implant. People with the withdrawn MoM hip replacements who experience pain should have this thoroughly investigated. Following the withdrawal of the DePuy device, and the MHRA guidance, the British Hip Society and the British Orthopaedic Association said:

    Everyone with a hip replacement that has been withdrawn should be informed and told that they will be under close clinical follow-up.
    Some form of follow-up should be carried out at least annually and patients should be given contact information so that they can be reviewed quickly if they have pain or lose function in their hip.
    Patients should be followed for the life of the implant until more data are available.
    If someone with a withdrawn MoM hip replacement experiences no pain or loss of function, no further investigations are required apart from standard follow-up.
    If a person with a withdrawn MoM hip replacement reports that they are in pain, the cause of the pain should be further investigated. Blood cobalt and chromium levels should be measured to indicate how much the device has worn, but there is no evidence that the implant must be replaced above a certain metal concentration.
    Treatment decisions should be confirmed with a second experienced “revision” surgeon.

People who have had a hip replacement, who are concerned, should contact their orthopaedic surgeon or GP. They should be given records of the type of hip replacement they had and receive the follow-up, if any, that is required.

If You have been diagnosed with chromium or cobalt metal toxicity from a metal on metal hip replacement call the DePuy Hip replacement Helpline and speak to amedical social worker today.

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.

Johnson and Johnson is on a Role with Recalls

Written by lisaspitzer on . Posted in Depuy Hip Replacement News

 

 

By Stephanie Baum, MedCity News | More Articles

December 24, 2011

 

Johnson & Johnson (NYSE: JNJ ) has issued its latest recall of Motrin, this time from retailers over slow-working tablets and caplets, bringing the number of recalls for this drug alone to six in the past two years and calling attention to the manufacturing woes faced by the drugmaker.

Johson and Johnson has been recalling products. We have the DePuy Hip Replacement as well as Motrin and the Transvaginal Mesh Devices

J&J subsidiary McNeil's consumer divisionrecalled 12 million bottles of Motrin coated caplets and tablets from retailers distributed in the United States, Puerto Rico, the Bahamas, Fiji, Belize, St. Lucia, and Jamaica.

 

It is the latest in a series of recalls the New Brunswick, N.J., company has issued, ranging from over-the-counter medication to hip replacements from its subsidiary, DePuy Orthopaedics. Analysts estimate DePuy's hip implants alone could cost Johnson & Johnson as much as $1 billion in lawsuits. The metal-on-metal hip implants were found to shed metal particles into a patient's bloodstream over time.

The DePuy Hip replacement Helpline receives calls  from people daily regarding the compications of their recalled DePuy.

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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