Monday, August 27, 2012

Additional insights into the Stryker Rejuvenate and ABG II Modular Neck Stem Implants Undergo Recall

Torrance, CA -- (SBWIRE) -- 08/23/2012 -- Csengeri Law experts in defective medical device law have offered several insights into the July 6, 2012 Stryker recall. Both Stryker Orthopedics Rejuvenate hip implants and ABG II modular neck stem have been recalled. The recall measures are voluntarily in the light of significant negative post market data. After 45 adverse results reported to the FDA in 2012 Stryker posted on their website that the units suffered “fretting and/or corrosion at or about the modular neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.” At the same time lawsuits surrounding defective metal-on-metal hip replacement units are growing as the implants display increasingly more consistent repetitive corrosion and toxicity patterns.

The Rejuvenate hip implant is a full hip implant whereas the ABG modular neck stem is a component used in several hip replacement systems, both units are undergoing recall. Stuart Simpson, Stryker hip reconstruction vice president and general manager issued the following statement regarding the recall. “While modular-neck stems provide surgeons with an option to correct certain aspects of a patient's anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopedics decided to take this voluntary action.” Essentially, the units corrode and generate metallic debris which can lead to a variety of health problems ending in implant failure.

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