DePuy ASR Metal on Metal Hip Implants were introduced worldwide in July of 2003. These hip Implants were first used in the United States in 2005. DePuy pushed the approval of the DePuy ASR Hip Implant devices through the FDA on what is known as the fast track. This expedited FDA approval process, commonly known as the 510(k) Process, allows medical devices to avoid the rigorous clinical trials if the manufacturer can show that the device is "substantially equivalent" to other medical devices already approved by the FDA. DePuy persuaded the FDA that the ASR XL Hip System was similar to previously approved metal-on-metal hip implants. DePuy claimed that the ASR XL Hip System did not "raise any new issues of safety or effectiveness."
The DePuy ASR Hip Implant devices were approved by the FDA because DePuy claimed they were "substantially equivalent" to three other hip implant devices. The three other hip implant devices were all also approved through the 510(k) Process, with the manufacturers claiming their devices were "substantially equivalent" to other approved medical devices. None of the devices had ever undergone the rigorous clinic testing.
Over the following months and years, DePuy and the FDA received hundreds of complaints regarding the DePuy ASR DePuy Hip Implant devices. The vast majority of these complaints resulted in early failures of the Hip Implant devices, which required removal of the device.
The typical life expectancy of a metal-on-metal hip implant device is 15 years. However, the DePuy ASR Hip Implant devices are failing at a much higher rate and much earlier than other metal-on-metal hip implant devices.
DePuy had long known of the high failure rate. As early as 2007, the Australian National Joint Replacement Registry had notified DePuy of the high failure rate of the DePuy ASR Hip Implant devices on at least 7 separate occasions.
The surgeon that designed the DePuy ASR Hip Implant device has admitted that both he and DePuy had knowledge of early failure rates due to the design of the device by at least 2008, yet DePuy continued to sell and market the DePuy ASR Hip Implant devices.
In December 2009, the Depuy ASR Hip Implant devices were recalled from the Australian market. The Australian National Joint Replacement Registry Director, Dr. Stephen Graves, stated the following, “It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”
In March 2010, DePuy first notified doctors in the United States of the high failure rate of the DePuy ASR Hip Implant system based upon the Australian Joint Replacement Registry data. However, DePuy did not issue a recall of the Depuy ASR Hip Implant device. Interestingly, months earlier, in late 2009, DePuy informed doctors that the company was discontinuing the sale of the DePuy ASR Hip Implant devices due to a decline in sales.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) issue medical device alerts on April 22, 2010 and May 25, 2010, warning of the dangers and health complications for patients with the DePuy ASR Hip Implant systems.
On August 26, 2010, DePuy announced the voluntary recall of the DePuy ASR Hip Implant systems.