Thursday, September 13, 2012

More on Stryker Rejuvenate Hip Implants

Virginia Examiner

Posted by Michael Phelan
Sunday, September 09, 2012 2:07 PM EST

in June 2008, Stryker Orthopaedics, a major U.S. medical device manufacturer, received FDA approval for its Rejuvenate Modular Hip System. FDA approval was based on Stryker's representation to the FDA that the design was substantially similar to a product that had already been approved by the FDA, Wright Medical Techology's Profemur Total Hip Modular Neck System. Thus, under the FDA regulatory approval system, the Rejuvenate Modular Hip System was essentially grandfathered in with very littlle pre-market scrutiny. P.S. Wright Medical's Profemur system was subsequently linked to high failure rates, resulting in many patients having to receive revision surgeries to remove the Profemur.

In February 2009, Stryker released its Rejuvenate Modular Hip System, and marketed it to more active, younger patients.

In April 2012, Stryker issued a field safety notice, an urgent Safety Alert warning doctors and distributors, of problems that have been identified with the company’s Rejuvenate prosthetic hips.

The urgent saffety alert warned that these artificial hips, made from varying combinations of metal, ceramic and polyethylene, are capable of improperly releasing potentially dangerous amounts of metal debris or metal ions into the bodies of hip replacement patients. Unlike the metal on metal hips which deal with problems from the articulation of a metal ball and cup, the problem with Stryker's Rejuvenate device involves the junction of the neck of the implant, which, according to Styker's urgent notice, may be subject to fretting and corrosion. Such fretting and corrosion can degrade the device's metal components, potentially putting patients at risk.

The adverse side effects can include metallosis (a build-up of metallic debris), necrosis (the cell death of affected tissues), and osteolysis (the death of bone cell due to blood supply issues) – any of which can necessitate revision surgery.

In May 2012, Health Canada recalled the Rejuvenate Modular Hip System. Stryker kept the device ont the U.S. market for a few months with new warnings and instructions. However, during that time the FDA continued to receive numerous complaints, which called into question the efficacy and safety of the device. Better warnings are useless if they cannot prevent the risks of the product.

So, in July 2012, Stryker recalled its Rejuvenate Modular Hip System and its ABG II modular-neck hip stems.
Stryker put up a website announcing its "voluntary recall" of Stryker Rejuvenate Modular and ABG II modular-neck hip stems. Here is the link to the Stryker website.

1 comment:

  1. I would suggest the plaintiffs to consult their orthopedic surgeon to determine whether or not the symptoms they might be experiencing are consistent with a failed hip replacement implant, and if that implant was manufactured and sold by Stryker.