Stryker has recalled two modular-neck stem hip implant components – the Rejuvenate and the ABG II. Stryker stated “potential risks associated with fretting and corrosion at the modular neck junction” as its reason for the recall. The fretting and corrosion may result in adverse tissue reactions or metallosis. The modular-neck stem implants subject to the recall are not metal-on-metal hips, such as the DePuy ASR, where both the acetabular cup and femoral ball are made of metal. As we have stated, in the metal-on-metal hips, metal debris caused by the friction between the metal head and cup can lead to adverse tissue reactions surrounding the implant.
The modular-neck stems experience abnormal wear at the modular-neck junction. A modular-neck design requires the metal femoral neck to be inserted into the metal femoral stem. In the typical hip non-modular stem implant, the femoral neck and stem are one piece. The advantage of the modular component is that surgeons are free to select from varying neck and stem sizes to achieve the correct fit for each client. However, the risk of modular-neck stems is the “fretting and corrosion” where the stem and neck overlap. The metal-on-metal neck/stem junction is under considerable stress after implantation. The stress can cause micromotion to occur at the junction, causing the metal stem and neck to rub together. The “fretting and corrosion” at the junction can result in metal debris that can lead to adverse tissue reactions, similar to the metal-on-metal hip implants.
This recall was triggered by more than sixty adverse event reports filed with the FDA’s MAUDE adverse event reporting system. Common symptoms of adverse soft-tissue reactions include swelling in and around implant site, pain in the groin, thigh or hip, rash, fatigue, and in-coordination. Anyone with either the Stryker Rejuvenate or ABG II modular-neck stem components should have their case investigated to determine its merits. If you need more information, contact Navan Ward at 800-898-2034 or by email at Navan.Ward@beasleyallen.com.
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