DePuy Orthopaedics unit of pharmaceutical giant Johnson & Johnson, has issued a recall of two of their products: the ASR XL Acetabular System, a hip socket used in hip replacements, and the ASR Hip Resurfacing System, a partial hip replacement which entails placing a metal cap on the femur reports The Seattle Times.
According to the report, the company is recalling the two products because of a high failure rate which requires that patients undergo a second hip replacement surgery.
The Federal Drug Administration (FDA) issued a letter dated August 19, 2010, to Depuy Orthopaedics which said, in essence, that the company marketed a hip implant for an unapproved use:
The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch™ Personalized Solutions System and the Corail® Hip System in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
DePuy spokesperson Lorie Gawreluk said that 93,000 of the hip devices have been implanted world wide. An earlier report by The New York Times said that the FDA had received 400 complaints from patients in the United States that their hip devices failed requiring them to undergo a second hip replacement.
In March of 2010, Johnson & Johnson said they were phasing out the artificial hip because of slowing sales. Although that is the spin that J&J took on phasing out the device, it seems apparent that the company must have suspected that the hip device had a design defect.
This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are Bellevue personal injury law firm with more than 30 years experience representing people in their product liability lawsuits. We welcome inquiries from people who have a DePuy hip implant and we provide a FREE and confidential case evaluation. Call us TOLL FREE at 1-800-244-9087 or use our CONTACT FORM.
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