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 into the natural femur (the top of the stem is flush with the top of the top of the patient’s 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 Food and Drug Administration 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.