The Rejuvenate and ABG II hip implants consist of four pieces:
1) cup or shell that is implanted in the pelvis
2) A metal femoral stem inserted in to the natural femur (the top of the stem is flush with the top of the top of the patients natural femur)
3) A modular femoral neck that is inserted into the femoral stem
4) A femoral head attached to the femoral neck that is then aligned with the cup implanted in the pelvis.
-The devices received FDA 510(k) approval in 2008. -The FDA posted the recall notice on its website on July 6, 2012 -The metal junctions at the femoral stem and the modular femoral neck (and between the modular femoral neck and the femoral ball if a metal ball is implanted) can rub together causing corrosion and/or fretting of metal devices. -Injuries include: elevated levels of heavy metals chromium and cobalt, pseudotumor, necrosis of tissue surrounding the implant, metallosis and in extreme cases systemic injuries such as headaches, tinnitus, etc.
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