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DePuy Hip Implants

In 2005, DePuy released its ASR XL Acetabular System and ASR Hip Resurfacing System. Given their metal-on-metal construction, these devices would help active adults with hip injuries achieve greater flexibility, allowing them to maintain their quality of life.

Within the five years the products were available, 93,000 people were implanted with the devices. However, thousands of them had problems with the hips, which DePuy later recalled. Subsequently, people are filing lawsuits to recover their losses.

DePuy and FDA Approval

The fact that these DePuy devices were made available is troublesome to begin with. The devices received approval by the U.S. Food and Drug Administration (FDA) called a 510 (k), which does not require clinical trials. This type of approval allows the company to release the implants if they are similar to other devices. While the general idea of the devices was similar, the design and makeup of the ASR was new. If the construction was tested, the results were not appropriately disclosed to doctors and patients. Some experts say that DePuy knew about the devices' higher-than-normal failure rates and did not reveal them. To make matters worse, some uninformed doctors used the devices for off-label use, which didn't require FDA approval at all.

Problematic DePuy Models

The ASR XL Acetabular System and the ASR Hip Resurfacing System models feature a ball-and-socket joint design that is completely made of metal. Other manufacturers construct models that may use metal but encase them in plastic or ceramic.

While the two DePuy models were anticipated to sustain a patient for decades, they were failing after only a few years. Once patients began reporting excessive pain and swelling near the implant, doctors found that the models were becoming detached. Doctors also found that the metal components rubbed against each other during regular movement, creating friction that caused the metal to erode. The result was pain that was often more severe than patients had experienced prior to receiving the device. Others have had to undergo revision surgery, which involves removing and replacing the problematic hip implant.

Complications and Recalls

DePuy voluntarily recalled these implants after patients reported pain, swelling and metal poisoning. Doctors found that the ionized metal that had flaked off the devices was collecting in joint spaces and triggering an immune response. Sometimes, patients experienced fluid-filled growths similar to tumors that had to be removed. Other patients had trouble walking, hearing and vision problems, heart conditions, mental and emotional changes, kidney impairment and skin rashes.

DePuy is offering financial assistance to those who required hip revision surgery as a result of their injuries, but these amounts have reportedly only covered immediate costs. As a result, many people are filing lawsuits to recover all of their losses.

If you have any questions regarding problems with DePuy hip devices, please contact us. We will answer your questions and help you understand your options.