DePuy ASR Acetabular Hip Replacement Recall
On August 26, 2010, DePuy Orthopedics, Inc., a division of Johnson & Johnson, announced a worldwide recall of two hip implant systems – the ASR XL Acetabular System and the ASR Hip Resurfacing System. The ASR™ XL Acetabular System is a hip socket used in traditional hip replacement, while the ASR™ Hip Resurfacing System is a partial hip replacement system that involves placing a metal cap on the ball of the femur. DePuy has estimated that 93,000 total devices have been implanted worldwide.
As the New York Times reported in March 2010, for more than two years, the Food and Drug Administration (“FDA”) has been receiving complaints that the devices subject of the announced recall have a high failure rate. In fact, since the beginning of 2008, the FDA reportedly received over 400 complaints involving United States patients. The FDA recently sent DePuy a warning letter regarding their knee and hip replacement devices, stating that the company has illegally marketed unapproved medical devices. .
Regarding the ASR™ XL Acetabular System, data now reveals that the five year revision rate is approximately 13 percent, while the five year revision rate for the ASR™ Hip Resurfacing System is approximately 12 percent. These revision rates are across the entire size range of the devices. The risk for revision is reportedly the highest with ASR head sizes below 50 mm in diameter and among female patients. The ASR systems have been under increasing scrutiny reportedly due to their metal-on-metal bearings which can generate debris from wear, in turn causing tissue damage and inflammation in some patients. In the fall of 2009, DePuy began “phasing out” the use of the ASR implant systems. .
DePuy has recommended that patients implanted with the affected devices visit their doctors for an evaluation and monitoring. DePuy has also said that it would pay “reasonable and customary” medical costs associated with its recall, including further surgery. However, that may not be nearly enough to cover the significant expenses, pain and continued suffering experienced by patients. Patients have suffered, and will continue to suffer severe injury, disability, lost wages, physical and mental pain and suffering, and possible death as a result of the defective implants – not to mention the effects felt by patients’ spouses and families. .
According to an Associated Press blog released today, this is the 11th recall issued by Johnson & Johnson (or a J&J subsidiary) since last September. .
Contact an Experienced Medical Device Recall Attorney
Kershaw, Cook & Talley are dedicated to protecting the legal rights of patients affected by the hip replacement device recall, and we are prepared to devote our substantial resources through trial. Our expert medical lawyers have represented thousands of victims of defective medical devices, dangerous drugs and consumer products in cases throughout the country, generating hundreds of millions of dollars in recoveries for our clients and the classes we have represented. .
If you or a loved one has had hip replacement surgery, you should contact your doctor to find out if the ASR Hip System was used. It is important that you do not sign anything from Johnson & Johnson or DePuy before speaking with a medical device recall attorney!
Symptoms of Hip Replacement Failure Include:
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