Zimmer Holdings, Inc (NYSE and SWX: ZMH) is temporarily suspending marketing and distribution of the Durom® Acetabular Component (Durom Cup) in the United States, while the Company updates labeling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S. The Durom Cup will continue to be marketed without interruption outside the U.S.
Zimmer is taking this voluntary action to address its concerns regarding reports of cup loosenings and revisions of the acetabular component used in total hip replacement procedures, in some patients who have been implanted with the Durom Cup in the U.S.
While many U.S. surgeons have had success implanting the Durom Cup, a subset have experienced elevated revision rates since the product was launched in the U.S. in 2006. These results contrast with product experience in Europe, where post-marketing data continue to show excellent clinical outcomes since the product launched in 2003. Following a comprehensive review of clinical experience and product conformance to specifications in the U.S. and Europe, Zimmer has found no evidence of a defect in the materials, manufacture, or design of the implant. The Company has identified that surgeons who regularly achieve the desired outcome with the Durom Cup consistently execute crucial technique steps and place the cup in a specific manner. Following its review, Zimmer has determined that revised surgical technique instructions and a surgical training program are required to more consistently achieve desired clinical results in the U.S. The Company has shared its review and conclusions with the U.S. Food and Drug Administration (FDA) and will continue to update the Agency.