DePuy ASR Hip Failed at Rate Too High to Be Kept On the Market

Johnson & Johnson, in conjunction with its DePuy Orthopedics subsidiary, announced at the end of August 2010 that it is recalling parts used for hip replacements. An estimated 93,000 people will be affected by the latest product recall. Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Patients who reported problems in the first five years and had revision surgery reported a variety of DePuy complications including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently.

DePuy has set aside $922 million to cover litigation costs. In its fourth quarter earnings, the company said its DePuy Orthopedics subsidiary faces a growing number of DePuy lawsuits over its ASR hip replacements. While the amount set aside will involve this money for settlements, in many people’s opinion it won’t be enough to satisfy all claims. The DePuy ASR hip recall was issued after the manufacturer acknowledged that the implant was associated with a higher-than-expected failure rate, often resulting in the need for revision surgery within a few years. Many recent lawsuits allege that a DePuy Pinnacle recall should be issued for similar reasons, as it contains a similar design and has also been associated with a large number of reported problems.

On May 6, the FDA ordered hip implant makers to conduct post market studies to gather data on the levels of metal in the blood of people who have received their hip implants and what health effects those implants might have. The agency sent a total of 145 post market surveillance orders to 21 different manufacturers, including DePuy Orthopedics. The American Academy of Orthopedic Surgeons (AAOS) issued a warning in October 2010 about potential the risk of DePuy metal poisoning from hip replacements, indicating that patients and the medical community should be aware that pain months after hip surgery may be a sign of cobalt toxicity.