DePuy ASR Lawsuit™
DePuy ASR Hip System Recalled
The Johnson & Johnson orthopedics division DePuy Orthopaedics, Inc. has officially announced a global recall of the ASR XL Acetabular System™ and the ASR Hip Resurfacing System™, due to a high rate of failure. Thousands of patients may have experienced unnecessary pain and the possibility of revision surgery.
The worldwide recall was announced in August, after a report from the National Joint Registry (NJR) of England and Wales revealed that the devices have a revision rate of approximately 12% and 13%, respectively. While these rates are across all device sizes, it was noted that device head sizes smaller than 50 mm in diameter, and devices implanted in female patients, had the highest rate of failure.
The specific failure occurring with these devices is related to the metal-on-metal design. Medical professionals have issued increasing numbers of warnings about metal-on-metal hip implants, and DePuy itself announced in 2009 that the design would be discontinued to focus on emerging technologies. Both the ASR XL Acetabular System and the ASR Hip Resurfacing System have been found to shed metal particles into the patient’s body, damaging soft tissue, causing inflammatory reactions and leading to eventual bone loss.
DePuy officials issued a press release announcing the recall and confirming 93,000 devices have been sold across the globe with the intention of implanting the devices in patients.
David Floyd, president, of DePuy Orthopaedics, stated via the press release, “We regret that this recall will be concerning for patients, their family members and surgeons,” said. “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.”
DePuy has also stated it will cover “reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.”
Lawsuits have already been filed in Los Angeles, San Francisco and Newark, New Jersey, alleging the company was aware of the design defects and chose to take no action, harming millions of innocent people.
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.
The U.S. Food and Drug Administration (FDA) and other global regulatory agencies have been notified of the voluntary recall.
