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DePuy ASR™ Recall

Hip Replacement Implant Recall

Individuals who have undergone hip replacement have something new to worry about- whether their device will fail. Industry leader Johnson & Johnson’s DePuy Orthopaedics division has announced the recall of two hip replacement devices, the DePuy ASR XL Acetabular System™ and the DePuy ASR Hip Resurfacing System™.

The global recall was announced in August 2010, after the National Joint Registry (NJR) of England and Wales reported the devices have a revision rate of 12%-13%. The ‘revision rate’ refers to the need for a revision, or second’, surgery to replace the original device.

The revision rate applies are across all device sizes. However, device head sizes smaller than 50 mm in diameter, and devices implanted in female patients, have the highest failure rate.

The specific failure reported to occur with the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System is thought to be caused by the metal-on-metal design, which medical professionals have issued increasing warnings about for some time. The manufacturer also announced in 2009 that the metal-on-metal design would be discontinued so the company could focus on emerging technologies.

DePuy confirmed 93,000 devices have been sold across globally with the intention of implanting these devices in patients.

Bloomberg News reveals that legal actions have already been taken against the ASR hip implant maker in federal and state courts in New Jersey and California. According to the Newark, New Jersey complaint, DePuy was “fully aware” the hip implant was defective, after receiving over 300 reports of ASR hip failures.

Johnson & Johnson acquired DePuy Orthopaedics in 1998. DePuy designs, markets, and does distribution for joint reconstruction. The company’s president, David Floyd, expressed regret via the press release, stating, “We regret that this recall will be concerning for patients, their family members and surgeons. We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.”Floyd went on to state DePuy Orthopedics is prepared to cover “reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.”

Patients who have undergone hip replacement surgery are strongly encouraged to visit their surgeons for proper evaluation of the implant’s performance.