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DePuy Orthopedic Recalls Faulty Hip Implants

In another example of medical device problems, industry giant Johnson & Johnson, along with its subsidiary DePuy Orthopaedics, announced a  recalled of  two acetyabular cups hip replacement systems, due to a high rate of failures and new data showing one in eight patients requires secondary hip replacement.

Every year, thousands of successful hip replacements are performed, bringing a better life to men and women around the world.  Unfortunately, this was not the case for patients who received a defective design following hip replacement surgery using either DePuy’s ASR Hip Resurfacing System™ or the ASR XL Acetabular Cups System™.

93,000 patients worldwide received the faulty replacement device.  Data compiled by the National Joint Registry (NJR) of England and Wales revealsthat a full 13% required additional surgery within five years. For this reason, it is strongly recommended that surgeons monitor hip replacement patients closely and perform evaluations as needed to ensure patient safety and comfort.

The recalled DePuy Orthopaedics ASR Hip Resurfacing System is a partial hip replacement system which uses a metal cap placed on the ball of the femur.  Also involved in the recall is the ASR XL Acetabular System, a traditional hip replacement system.  Both systems use a metal-on-metal design which was discontinued by the manufacturer in 2009. The primary issue is that, as the metal parts move together, metal debris is shed into the patient’s body, leading to pain, immobilization, inflammation, bone loss and other health concerns. Other potential issues include loosening of the cup and detachment from the bone, dislocation, and fractures.

Bloomberg News reports legal actions have already been taken against Johnson & Johnson in both federal and state courts in New Jersey and California. Thousands of additional lawsuits are expected, as the investigation continues into the faulty devices.

In an August 2010 press release, DePuy president David Floyd expressed regret over the recall, stating, “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 also remarked that DePuy will cover “reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.” DePuy has notified The U.S. Food and Drug Administration (FDA) and other global regulatory agencies.

U.S. and Canadian patients and members of the medical community seeking additional information about the devices and the recall may visit www.DePuy.com, or call 888-627-2677 Monday-Saturday, 8 a.m. to 9 p.m. EST. Patients outside the U.S. and Canada may call collect, +1 813-287-1651 24, hours a day, seven days a week.