DePuy Hip Replacement Failures Lead to Massive Recall
Published On: November 13, 2011
People with a DePuy ASR hip replacement implant are experiencing a high rate of failure and pain associated with this device, sometimes shortly after surgery. See New York Times Johnson & Johnson Recalls Hip Implants
People with the DePuy ASR have filed lawsuits because, despite reports of injury with this device, the manufacturer failed to inform doctors and patients of the known risks associated with this device and waited to issue a DePuy recall until August 2010.
The Manufacturer of the DePuy ASR has Issued a DePuy Recall Due to a High Rate of Failure (Bloomberg). The DePuy ASR is a Metal on Metal (MoM) prosthetic device consisting of a ball and corresponding socket implanted in thousands of patients around the world during hip replacement surgery. DePuy Orthopaedics, Inc., the medical device maker and part of the Johnson & Johnson Family of Companies, marketed this hip prosthetic in a “resurfacing” version called DePuy ASR Hip Resurfacing System and as total hip replacement called the DePuy ASR XL Acetabular System.
Since 2008, there have been more than 300 complaints about this device filed with the U.S. Food and Drug Administration (FDA), with more than 90% of these cases requiring another hip replacement surgery to replace the defective implant. Still, there was no DePuy recall. See FDA Warning Letter to DePuy Orthopaedics, Inc.
The design of the device made it difficult for surgeons to implant, causing improper fusing with the bone and loose implants. Friction from movement of the metal on metal socket also creates metal shavings or debris in the soft tissue surrounding the device, causing pain, inflammation and necrosis or tissue death. This damage and inflammation can cause severe pain and disability, can be irreversible and complicate future replacement surgery. MoM hip implants, such as the DePuy ASR also release metal ions into the body.
In 2009, the manufacturer voluntarily removed the DePuy ASR from the Australian market due to the device’s high failure rate, but they failed to issue a DePuy recall in the U.S. and doctors unknowingly continued use of the devices for patient’s hip replacement surgery. The company notified U.S. physicians about the Australian higher than anticipated failure rates in a March 2010 letter, only advising physicians that proper surgical positioning of the implant was essential.
On August 26, 2010, DePuy Orthopaedics, Inc. finally issued a DePuy recall, citing that 12%-13 % of patients with these defective implants would need to have a revision surgery.
Justice For Your Injuries
If you or a family member or close friend has undergone a DePuy hip replacement that has been the subject of this recall, you may have the right to file a lawsuit against the manufacturers (namely Johnson & Johnson and DePuy Orthopaedics, Inc.).
Contact me to evaluate your concerns and provide you with the utmost in legal guidance.