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Depuy ASR Class Action

Depuy™ Hip Replacement Recalled

If you have a Depuy ASR XL Acetabular System™ for Total Hip Replacement (ASR Hip System), this is important news.

Depuy™ Orthopedics, a Johnson and Johnson division, recently issued a global recall of the ASR Hip System, stating design failure which may include shedding of particles into the patient, resulting in painful, serious reactions andpossible further surgery.

The decision was based on data reported by The National Joint Registry (NJR) of England and Wales that a high percentage of five year secondary or revision hip surgeries were occurring in patients who had received The ASR™ XL Acetabular System. This ‘high percentage’ works out to 1 out of every 8 patients, or 93,000 patients worldwide who have undergone hip replacement with the ASR XL Acetabular System or the ASR Hip Resurfacing System.

Based on these findings, the manufacturer announced a global voluntary recall of the ASR Hip system, notifying the U.S. Food and Drug Administration (FDA) and other regulatory agencies of their plans to remove the device from the market.

The worldwide recall involves both the ASR XL Acetabular System, a traditional hip replacement device, and the ASR Hip Resurfacing System, a partial hip replacement device. Only the ASR XL is approved for use in the United States.

Depuy™ Orthopedics released this public statement:

"Data recently 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, called a revision surgery. For this reason, DePuy Orthopaedics is voluntarily recalling its ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. This recall means additional testing and treatment may be necessary to ensure the hip is functioning well. In some cases, patients may need additional surgery."

Federal and state lawsuits have been filed in San Francisco, Los Angeles, and Newark, New Jersey, contending that Dupuy™ was aware the ASR hip implants required corrective surgeries because of flaws in the products’ design. The lawsuits also allege that DePuy™ had received more than 300 reports of corrective surgeries required because the ASR Hip System was flawed, but took no action to protect the 93,000 patients who had received the devices.

Dupuy™ had previously decided in 2009 to discontinue the ASR Hip System in order to focus on emerging replacement and resurfacing technologies.