Tracking the DePuy Hip Replacement System Failure

DePuy Orthopedics, a subsidiary of Johnson & Johnson, began marketing its ASR TM XL Acetabular hip replacement system and ASR Hip Resurfacing System in 2005, after having obtained 501(k) premarket notification from the Food and Drug Administration (FDA). A 501(k) allows a medical device manufacturer such as DePuy to market a new product based on comparison studies to similar products, rather than by conducting clinical trials.

However, in 2008 — just three years after release — many patients issued complaints with the FDA and other global regulatory authorities for painful swelling, muscle and tissue damage, and even total hip failure. DePuy did not comment on these complaints, even though in early 2010 the company announced it would begin phasing out the ASR system due to "low sales."

It was not until March 2010 that Johnson & Johnson, DePuy's parent company, formally acknowledge that the DePuy ASR XL Acetabular system had a "higher-than-normal" failure rate. Several studies begun in 2008 when complaints were first issued and others thereafter indicate about 12 to 13 percent of patients — or one in eight people — require a second surgery to repair damage caused by the ASR system.

Finally, due to mounting pressure from the FDA, the health care industry and the general public, in August 2010 DePuy issued a voluntary recall of 93,000 hip replacement/resurfacing units thought to be defective. Twenty-nine models were included in the recall, including the ASR 100 and 300 Acetabular implants sized 44mm to 70mm.

What Causes DePuy Hip Failures?

While the causes of a DePuy ASR hip implant failure are currently under investigation, many surgeons have reported design flaws since the system's introduction into the market. According to these medical experts, the implant's overall design makes it difficult to place at the proper angle, increasing the likelihood of hip failure.

Once the implant begins to fail, the metal femoral head can rub against the metal acetabular cup. This metal-on-metal friction may release metal ions into the surrounding soft tissue and bloodstream, leading to inflammation, swelling and possible metal poisoning. The metal ions also prevent the implant from bonding to the natural hip, leading to dislocation or even total hip failure.

Contact Miller Weisbrod

If you or a loved one has suffered serious medical complications due to a DePuy ASR hip implant failure, the Texas attorneys of Miller Weisbrod, LLP, have the experience and client-oriented service you need. Please call our main offices in Dallas at 214.987.0005 to schedule a free consultation.

We handle cases nationwide. If you are calling from outside the DFW Metroplex, please call our toll-free line at 888.987.0005, or contact us by e-mail to schedule an appointment or request additional information.