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Published: August 12th, 2008
A number of surgeons in the United States have reported a higher than expected rate of failure and loosening of the Zimmer Durom Cup, often requiring revision surgery. In July 2008, Zimmer suspended sales of the Durom Acetabular Component (Durom Cup) until they can update the label with instructions about special surgical techniques that need to be followed during total hip replacements. Unfortunately, over 12,000 patients in the U.S. already received the artificial hip component from doctors who were not provided proper instructions or training.
STATUS OF ZIMMER HIP REPLACEMENT LAWSUITS: Lawyers throughout the United States are reviewing potential Durom Cup Lawsuits against Zimmer for failing to provide proper warnings, instructions and training to surgeons.
MANUFACTURER: Zimmer Holdings, Inc.
OVERVIEW: The Zimmer Durom Acetabular Component is a newer type of artificial hip part which is designed for use in combination with Zimmer’s Metasul Metal-on-Metal Tribological Solution Large Diameter Heads (LDH). The hip replacement cup is a monoblock of cobal chromium alloy which was introduced in Europe in 2003 and approved in the United States in 2006.
Unlike traditional hip replacement parts, the Zimmer Durom Cup is made from a single piece of material and is designed to address some of the more common problems with hip replacement components, such as wear of the bearing, limited range of motion and instability.
ZIMMER DUROM CUP HIP REPLACEMENT PROBLEMS: Since the Zimmer Durom Cup was approved for use in the United States during total hip replacements, also known as total hip arthroplasty, a number of doctors have encountered problems where the artificial hip parts loosened or otherwise failed, requiring additional surgical revisions.
In April 2008, Dr. Larry Dorr, a prominent orthopedic surgeon, wrote an open letter to members of the American Association of Hip and Knee Surgeons about Zimmer Durom Cup problems he had encountered. At that time, 14 out of 165 total hip replacements he performed with the Zimmer Durom Cup were revised or required revision within the first two years. He indicated that he did not believe the fixation surface on the cup was good, and that a circular cutting surface on the periphery of the cup prevented it from fully seating.
In May 2008, Zimmer sent a letter to healthcare providers indicating that they were initiating an investigation into the complaints of Zimmer Durom Cup complications. After reviewing data on over 3,100 cases, Zimmer suspended sales of the Durom artificial hip component in July 2008.
A Zimmer Durom Cup recall was not issued, since they indicated that there was no manufacturing defect or design defect with the components. They indicated that sales would be resumed once additional product labeling was developed to provide instructions about special surgical techinques that are required to avoid problems. They also indicated that a new surgical training program would be implemented in the United States, since the technology and design parameters of the Durom Cup require a higher degree of precision than the more common hip replacement surgical techniques used in the United States.