Zimmer NexGen CR-Flex, LPS Flex and MIS Tibial Components Recalled Because of Failure Rate
Posted by Hadley MatarazzoThe Zimmer NexGen CR or cruciate retaining knee replacement device is a subgroup of Zimmer’s popular NexGen total knee replacement series, which includes the CR-Flex and LPS Flex. Individuals implanted with these components have experienced loosening, pain and device failure requiring revision surgery. These components were designed for people with healthy bones and intact cruciate ligaments and are recommended for individuals undergoing first-time knee replacements. The CR-Flex is unique in that it is not secured by surgical cement, but instead is supposed to attach to the patient’s thigh bone. Based on numbers provided by Zimmer, it is estimated that thousands of these devices were sold by 2010.
At a March 2010 conference of American Academy of Orthopaedic Surgeons, a group of orthopedists presented data on 108 Zimmer NexGen Knee replacement patients from Rush University Medical Center in Chicago. The data shows that 9% of the patients had to undergo revision surgery within two years of the initial implantation of the Zimmer NexGen CR-Flex Knee. In addition, 36% to 39% of the patients reported pain and loosening of the implant indicating that the failure rate could reach as high as 39%. More…
