DePuy Orthopaedics, a division of Johnson and Johnson, announced on Thursday that it would recall two models of hip replacement implants because they failed earlier than expected, causing patients to undergo a second "revision" surgery.
The models in question are the DePuy ASR XL Acetabular System and ASR Hip Resurfacing System and total 93,000 worldwide, the company said.
The devices were often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery. They were discontinued in 2009.
While the "the majority" of hip replacement surgeries were a success, the company says it is advising patients with the recalled devices to seek evaluation by their surgeon.
A few data points about the recall, as outlined by new data from the National Joint Registry of England and Wales:
- The five-year revision rate for the ASR Hip Resurfacing System is about 12 percent.
- The five-year revision rate for the ASR XL Acetabular System is about 13 percent.
- The risk for revision was highest with ASR head sizes below 50mm in diameter and among female patients.
- Previous surveillance data showed lower revision rates, even though the ASP hip was performing "in line with other devices in its class.
DePuy said it intends to cover "reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR."
Beginning Aug. 27, patients in the U.S. and Canada can call 888-627-2677 from Monday to Saturday, 8 a.m. to 9 p.m. EST. (Patients in other countries can place a collect call to the U.S. at +1 813-287-1651 anytime, 24 hours a day, seven days a week.)
This post was originally published on Smartplanet.com