Wednesday, August 1, 2012

Stryker Hip Replacement Recall Second This Year

 Reprinted from  the Digital Journal

Stryker Orthopaedics announced last week the voluntary hip implant recall of the Rejuvenate Modular and ABG II modular-neck hip stems due to the risk of fretting (wear-and-tear) and corrosion at or about the modular-neck junction. The hip replacement failure results in adverse events such as local tissue reactions indicated by swelling and pain.

There have been multiple hip replacement complications since the year 2000, which prompted the FDA to order hip manufacturers in May 2011 to collect more safety data about metal-on-metal hip replacements.* The Stryker recall is the latest withdrawal of a metal-on-metal hip from the market.
Like many other hip implants, Stryker hip implant parts have never been subjected to clinical trials. Several hip implant devices have been approved for use by way of the 510(k) regulation that allows fast-track approval when a device is judged to be substantially similar to a model that has already undergone clinical testing.**

There is now compelling evidence that metal on metal (MoM) implants fail at a higher rate than hip implants made from other materials. One type of metal-on-metal hip has a failure rate of nearly 50 percent at six years. This is a surprising result since the metal-on-metal hips were marketed as being more resilient than earlier models.

Hip implant recipients are encouraged to consult with their physicians to determine whether a recalled Rejuvenate Modular and ABG II component was implanted. There have been several hip replacement recalls during the last few years, and there may be a premature hip implant failure in the future. It’s vital to contact a physician immediately when there is any hip implant pain.

DePuy recalled their ASR hip implant in 2010,**** and the DePuy Pinnacle hip replacement has had numerous adverse event reports. Zimmer recalled their Durom Cup system in the US on July 22, 2008, ostensibly because the instructions were inadequate for surgeons to properly install their device. On June 1, 2012, British manufacturer Smith & Nephew recalled their metal liner of the R3 Acetabular System. This many hip issues have prompted thousands of hip replacement lawsuits.

No comments:

Post a Comment