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Hip Replacement Patients at Possible Risk, Cleveland Law Firm Adds Zimmer Durom Cup Lawsuit Info on SpangLaw.com
Date:1/15/2009

nce less bone removal was required than with conventional total hip arthroplasty (THA.) In late Fall 2007, however, Zimmer's foreign counterparts received reports that the product showed a "high amount of wear due to malpositioning of the cup after about one year." Notwithstanding this warning, the Durom® Cup continued to be marketed and implanted by surgeons in the United States who were unaware of the problems encountered in Europe.

In April 22, 2008, just two years after the implant was released into the U.S. market, a nationally recognized orthopedic surgeon, Larry Dorr, M.D. warned his colleagues within the American Association of Hip and Knee Surgeons of an unacceptably high failure rate. Specifically, he had found that 14 of the 165 Durom® hip cups implanted had required a revision surgery - a failure rate that far exceeded those of other available implants. Because the implants easily popped free during the revision surgeries, Dr. Dorr's team concluded that the patients' hip bone had been unable to incorporate the implant likely because of defects in the cup's design and surface coating.

In response to Dr. Dorr's warning, Zimmer informed surgeons that it was internally investigating the complaints. In an apparent attempt to reassure surgeons of the implant's safety, Zimmer cited to its own clinical trials and international experience dating back to 2003. Within the same letter, however, Zimmer acknowledged that the U.S. version of the implant was not identical to the European version.

Following Dr. Dorr's warning and Zimmer's response, the Food and Drug Administration received several 'adverse event reports' concerning this possible defective medical device. Under mounting pressure, on Jul
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