After discovering an unexpected number of hip implant failures, Zimmer Inc. voluntarily recalled one of its artificial hip implants, the Zimmer Durom® Cup. Some of the patients who must now undergo expensive and painful revision surgery have filed product liability lawsuits against Zimmer Inc. alleging defects in the acetabular cup. Personal injury attorneys expect the number of lawsuits arising from the Zimmer Durom® Cup Recall to grow as more patients experience failures.
Cleveland, Ohio (PRWeb) January 14, 2009 — Initially approved for market in March 2006, the company touted the Zimmer implant as superior for active patients since 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 July 22, 2008, Zimmer temporarily suspended marketing in the U.S. or voluntarily recalled the device. In what appeared to be an attempt to blame the implanting surgeons’ technique, Zimmer claimed that “revised surgical technical instructions and a surgical training program” were required “to achieve desired clinical results in the U.S.” In an apparent about-face, however, Zimmer later told at least some of the patients requiring revision surgery that it did ‘not fault’ the surgeons and was “taking the responsibility for corrective action.”
Despite Zimmer’s purported commitment to take ‘corrective action,’ several patients have formally filed Zimmer Durom® cup lawsuits alleging defects in the implant. These numbers are expected to climb as more patients experience failures and are advised of their legal rights. Personal injury attorneys and law firms, like Rhonda Baker Debevec, Esq. and Nicholas A. DiCello, Esq. of the Cleveland, Ohio firm Spangenberg Shibley and Liber Law Firm, are investigating potential claims on behalf of the estimated 12,000 patients implanted with the device.
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