Metal on Metal Hip Implant RECALL

Online, July 17, 2012 (Newswire.com) - Metal on Metal Hip Implant RECALL

Stryker Orthopaedics is leading manufacturer of Orthopaedic Implants used in Joint replacement surgery.

On July 6, 2012 Stryker voluntarily recalled its Rejuvenate Modular Hip Implant System and its ABG II modular-neck hip stems due to potential risk of significant "fretting" and/or corrosion. The Stryker Rejuvenate Modular Hip Implant System, metal-on-metal (MoM) implant was given FDA clearance through the 510(k) process in 2008. The 510 (k) process is an expedited FDA process that gives "clearance" to a medical device which the FDA deems substantially equivalent to another device that has previously received FDA approval. Since 2008, a significant number of adverse events have been reported concerning the Stryker Rejuvenate Modular Hip Implant System.

MoM hip implants have generated controversy in the medical field due to a significant failure rate. Over time, fretting or corrosion of the metal implant can cause metal fragments to enter the bloodstream causing metallosis or metal poisoning within patients. Metallosis may lead to shock, anemia or kidney failure if left untreated. This research is the reason for the Hip Implant Recall.

Post-market studies of metal on metal hip (MoM) implants were ordered by the FDA in May 2011 and an advisory panel was formed. The FDA Advisory Panel has not yet released its findings. We are anxiously awaiting the release of the findings.
Roselli & Associates, P.A. is investigating metal-on-metal hip implant claims involving Stryker as well other Orthopaedic Implant Manufacturers including Smith and Nephew, Wright Medical Group and Zimmer.

If you or loved one is suffering from the ill-effects of a metal-on-metal hip implant, contact us at 954-560-0700 or 1888 ROSELLI (1888- 767-3554) or Email us at info@JusticeMatters.com