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Recall of Nexgen Complete Knee Solution Knee Replacement Components
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Zimmer Inc. has initiated a Class 2 recall of the Nexgen Complete Knee Solution MIS tibial components, locking screw and stem extensions. The U.S. Food and Drug Administration issued a notice regarding the recall on September 13, 2010. The FDA Notice may be found HERE, which lists the specific codes for the recalled devices.
As of the date of the notice, there had been 114 reports filed with the FDA reporting that the device loosened, requiring patients to undergo surgery to replace the device. Immediately after the recall, Zimmer sent an “URGENT DEVICE CORRECTION” letter to orthopedic surgeons who had used the device. Zimmer warned surgeons to destroy or disregard all previous versions of the surgical technique and to review and familiarize themselves with the revised technique in light of the recall.
If you or a loved one underwent knee replacement surgery in which a Nexgen device was used, you ultimately may need to undergo surgery to replace the defective Nexgen device. Symptoms that may indicate a failure of the device include knee and joint pain, difficulty standing or walking, decreased range of motion, and soreness or stiffness.
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Posted By DeCarli Law on
February 11, 2011 05:33 pm |
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