DePuy ASR™ Recall

DePuy Orthopaedics, Inc. (the orthopedic arm of Johnson & Johnson) issued a global recall of two of its hip implant devices--the ASR™XL Acetabular System and the ASR™ Hip Resurfacing System. This recall follows a New York Times article on March 10, 2010, which revealed that DePuy Orthopaedics, Inc. had halted sales and issued an urgent safety notice for its DePuy ASR™ Hip device systems. Recently, the FDA issued a warning letter to DePuy for selling hip and other joint products without the agency's approval.

DePuy sold around 93,000 of the units.

The DePuy ASR™ hip devices are metal-on-metal hip replacement systems. The natural hip joint is like a ball that fits in a socket. The socket portion of the hip is called the acetabulum. The femoral head at the top of the thigh bone (femur) rotates within the curved surface of the acetabulum. According to DePuy, the recalled hip implants utilize a one-piece acetabular cup, which is a metal liner that replaces the acetabulum.

With the recalled ASR XL Total Hip Replacement System, there are three components:

1) The femoral stem is inserted inside the femur
2) The femoral head (or ball) connects to the stem, and
3) The stem then fits inside the acetabulum.

The second recalled ASR hip device—the DePuy ASR Hip Resurfacing System—utilizes two components:

1) A cap is placed over the natural femoral head and
2) The acetabulum is replaced with the one-piece cup.

DePuy has announced that data received by the company shows that more people than expected who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery. Information showed that five years after implantation, approximately 12% of patients, or 1 in 8, who had received the ASR resurfacing device, and 13% of patients, or 1 in 8, who had received the ASR total hip replacement needed a second surgery. The recall means that monitoring and testing may be necessary of individuals who have been implanted with either of the DePuy ASR Hip Systems.

If you are uncertain if you have either of the recalled Hip Systems, contact your orthopedic surgeon, your primary care physician or the hospital where the surgery took place should be able to provide you with the name of your surgeon if you can't recall who performed the original surgery.

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