DEPUY HIP IMPLANT RECALL

On August 26, 2010, following approximately 400 FDA complaints since 2008 and new clinical data, Depuy Orthopedics, a division of Johnson & Johnson, announced the voluntary recall of two products for hip replacement surgery, ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System.The DePuy hip implants recall was motivated by the results of a study conducted by the British Medical Journal and published on March 2010. The new data indicated that 12% of the patients with ASR resurfacing device and 13% of those with DePuy ASR total hip replacement systems would likely need to undergo revision surgery within five years of implantation.(2) This failure rate is twice the average industry rate.(3)

The Depuy Implant recall may affect 93000 patients worldwide, though not all of those patients will suffer side effects or revision surgeries. New clinical data suggests that the defective hip replacement systems could cause revision surgeries in 12-13% of all the patients.

What are ASR Hip Implants?

ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System have been used in artificial hip surgeries for the last 7 years. The Acetabular system was used as the total replacement of hip in order to alleviate pain and disability, caused by osteoarthritis and rheumatoid arthritis; and the hip resurfacing device was used to save hip bone during bone-conservative surgery procedure,i.e, resurfacing arthroplasty.(3)

What are the Reasons for DePuy Hip Implants Recall?

DePuy ASR hip implant products belong to the “metal-on-metal” implant category. These types of devices have historically caused concern among orthopedic surgeons in view of serious bone damage and tissue inflammation, often requiring replacement surgery within the first couple of years after implanting. The hip implant consists of two metal components – the ball, which replaces the head of femur, and a acetabular cup, where this ball moves when a human moves his leg. Over time, the dry friction of these metal elements causes the formation of wear debris-–small metal particles—which may cause multiple medical complications involving physical discomfort, swelling, pain, and even genotoxicity (when bone marrow or white blood cells are exposed to metal particles, resulting in the increased risks of cancer and heritable defects).(4)

The DePuy hip implants recall was motivated by the results of a study conducted by the British Medical Journal and published on March 2010. The new data indicated that 12% of the patients with ASR resurfacing device and 13% of those with DePuy ASR total hip replacement systems would likely need to undergo revision surgery within five years of implantation.2 This failure rate is twice the average industry rate.(3)

What Does DePuy Hip Implants Recall Offer?

DePuy is recalling all ASR™ XL Acetabular Head System and DePuy ASR™ Hip Resurfacing System, implanted after July 2003. If you have questions, you may contact Joseph Lyon at www.thelyonfirm.com for more information.