DePuy Synthes, acquired by Johnson and Johnson in 1998 is one of the orthopedic franchises involved in manufacturing, designing, marketing products for repairing, reconstructing, correcting, various bone fractures and joint deformities. DePuy provides following product for Hip Replacement Surgery: DePuy Articular Surface Replacement (ASR) Hip Resurfacing System, ASR XL Acetabular System for total hip replacement and Pinnacle hip replacement system being their top hip replacement products.
The DePuy Pinnacle was initially approved by the U.S. Food and Drug Administration (FDA) in 2000. The 510(k) approval was based on similarities to the other implant and hence did not undergo the usual safety tests. ASR and ASR XL have been recalled in 2010 for its failure, whereas the sales of metal Ultamet liner ended in May 2013. However, the sales of Pinnacle hips made from other materials were not affected.
DePuy stated the reason for failure as component loosening, infection, dislocation, component malalignment, fracture of the bone, metal sensitivity and pain. Additional complications include bone staining, necrosis, swelling, increased metal ion levels in the blood, nerve damage, tissue damage and/or muscle damage.