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Orthopedic device manufacturer Zimmer Holdings, Inc. announced it is temporarily suspending U.S. marketing and distribution of its Durom Acetabular Hip Replacement Component (the "Durom Cup") in response to numerous complaints of device failure, including cup loosening requiring subsequent revision surgery.
The Durom Cup was first introduced in the United States in 2006 for use in total hip replacement procedures. According to the manufacturer, over 56,000 Durom acetabular components have sold worldwide, with over 12,000 of these sold in the U.S.
On April 22, 2008 prominent Los Angeles orthopedic surgeon Dr. Larry Dorr publicly notified the American Association of Hip and Knee Surgeons (AAHKS) of the failure rate associated with implantation of the Durom Cup artificial hip replacement component. Specifically, Dr. Dorr reported that within the first two years following implantation, 14 out of 165 patients of his who received the Durom hip replacement system had to undergo revision surgery to correct a failed device.
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