DePuy Orthopaedics, a subsidiary of Johnson & Johnson, recently announced a voluntary recall of two hip replacement products, due to a high rate of patients needing a second replacement.
Below are the hip devices involved in the recall:
ASR XL Acetabular System, a total hip replacement system sold worldwide.
ASR Hip Resurfacing System, a partial hip replacement available in countries outside the United States.
More than 93,000 of these hip replacement systems have been implanted worldwide, according to DePuy.
In March, the New York Times reported, that for more than two years the U.S. Food and Drug Administration (FDA) had been receiving complaints that the devices failed early in some patients requiring painful, costly operations. Since 2008, the FDA has received more than 400 complaints involving patients in the U.S. who received the devices, said an agency spokeswoman.
Reason for the ASR Recall
The recall was initiated after DePuy received data that shows "more people than expected (about 12 percent or 1 in 8) who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery," according to a statement on the company’s Web site.
What the recall means for patients
These systems first became available in July 2003. If your hip surgery was prior to that date, the hip you received is not subject to this recall. Please speak to your orthopaedic surgeon about any questions you have regarding your hip replacement.
If you know you have one of the recalled hip systems, you should schedule a follow-up appointment with your surgeon to evaluate how your hip is functioning. Symptoms, if present, may include an increase in pain or difficulty walking.
DePuy intends to cover reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, associated with the ASR recall.
