temporarily suspending marketing and distribution of the Durom Acetabular Component in the U.S. on a voluntary basis, while the Company updates labeling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S.
Sarasota, FL (PRWEB) August 12, 2008
The Maglio Christopher & Toale Law Firm has filed suit in Federal District Court against Zimmer, Inc. on behalf of a client with a failed Durom Hip Replacement Cup. Zimmer is a multinational medical device manufacturer. It is believed that this is the first lawsuit to be filed against Zimmer regarding its controversial Durom Hip Replacement System. The Firm plans to file additional Durom lawsuits against Zimmer on behalf of other clients in the coming weeks.
Problems with the Zimmer Durom were put in the spotlight on April 22 of this year when a highly respected orthopedic researcher, surgeon, and director of the Dorr Institute for Arthritis Research and Education, wrote a letter to his colleagues at the American Association of Hip and Knee Surgeons, criticizing the device. In his letter, Lawrence Dorr, MD, reported that 14 of the 165 Durom hip systems implanted at his clinic needed to be surgically revised within two years of implantation. He wrote:
"In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). These early cups fooled us, but the symptoms were so classic for a loose implant that we operated on the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions."
It was another three months before Zimmer finally stopped selling its Durom Hip Resurfacing System. On July 22, 2008, Zimmer issued a press release announcing that it was "temporarily suspending marketing and distribution of the Durom Acetabular Component in the U.S. on a voluntary basis, while the Company updates labeling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S."
In its release, Zimmer admitted that the Durom cup was failing at a higher than expected rate. However, it went on to blame the high rate of failure on surgeon error rather than on the Durom cup. Orthopedic surgeons familiar with the Durom have disagreed, indicating that the widespread nature of the failures shows the problem to be with the cup and not surgeon error.
Zimmer estimates that as many as 12,000 patients in the United States currently have the Durom Cup implanted in their hips.
About the Maglio Christopher & Toale Law Firm
The Maglio Christopher & Toale Law Firm has successfully represented patients across the nation in obtaining compensation for injuries caused by defective hip and knee joint replacement devices.
Press inquiries on this matter please contact:
Altom M. Maglio, Esq.
Maglio Christopher & Toale Law Firm
1751 Mound Street, Second Floor
Sarasota, Florida 34236