Due to a fairly high percentage (12-13%) of five year revision or secondary hip surgeries DePuy Orthopaedics, Inc. reported based on this year's data from the National Joint Registry (NJR) of England and Wales, the manufacturer announced this week it is voluntarily pulling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System from the marketplace. DePuy has notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally of the voluntary recall.
The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices preferred by surgeons for young patients who may benefit from the stability of the device, thus limiting the chance of repeated dislocation. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide.
The risk for revision was highest with women utilizing ASR head sizes below 50 mm in diameter.
As the numbers suggest, most ASR hip replacement surgeries are successful. However, Depuy is strongly suggesting patients utilizing an ASR device immediately see their implant surgeons for a full evaluation of performance.
President of DePuy Orthopaedics David Floyd released this statement:
We regret that this recall will be concerning for patients, their family members and surgeons. 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 will cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.
Patients and health care professionals with questions related to this recall should visit depuy.com. As of August 27, patients in the U.S. and Canada can contact DePuy by calling 888-627-2677 Monday-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 24 hours a day, seven days a week.
It is interesting to note that DePuy decided in 2009 that it would be discontinuing the ASR System because of declining demand and the obvious need to focus on modern replacement and resurfacing emerging technologies.
Written by Sy Kraft (B.A. Bachelor of Arts - Journalism - University of California, Santa Barbara or California State University, Northridge)