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July 6, 2012
Howmedica Osteonics Corporation (doing business as Stryker Orthopaedics)
Rejuvenate Modular-Neck Stem
ABG-II Modular-Neck Stem
The recall applies to all Rejuvenate devices sold from February 2009 to July 6, 2012 and all ABG-II devices sold from November 2009 to July 6, 2012. It is estimated that Stryker sold as many as 30,000 of these devices worldwide, including 20,000 in the U.S.
There are two types of femoral stems used in total hip replacements: Monoblock and modular-neck stems. The traditional monoblock stem is a one-piece stem and femoral neck. The modular-neck stem consists of two pieces – a neck and a stem. The stem is inserted into the patient’s femur. The neck is then inserted firmly into the femoral stem. Both pieces are made of metal (cobalt, chromium and titanium).
Reason for the Recall
According to Stryker, the Rejuvenate and ABG-II modular-neck stems are prone to “fretting and corrosion.” Wear and tear around the femoral neck taper junction causes metal particles to be released from the implant into the hip cavity and bloodstream. As a result, patients may experience severe pain, swelling, tissue and bone damage and premature failure of the devices (often requiring revision surgery, or removal and replacement of the hip stem).
Since 2008, medical researchers have warned that modular-neck stem devices, unlike traditional monoblock stems, can fail due to fretting and corrosion. Studies over the next three years confirmed initial reports of premature failure of these devices due to the release of metal particles from the friction around the modular-neck taper junction.
To learn more about the recalled Stryker hip implants, contact Belt & Bruner. A lawyer can provide a free consultation about your case and help you to determine your legal options.
For More Information
• Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Action Specific to Rejuvenate and ABG II Modular-Neck Stems, U.S. Food and Drug Administration