A study presented to the American Association of Orthopedic Surgeons indicated that after just two years of use, the Zimmer NexGen CR-Flex Porous Femoral knee replacement component was experiencing high failure rates of 9.3 percent. Also, 36 percent of the 108 patients studied reported pain and loosening of the defective implant in that two-year time frame. The Zimmer component was intended to last 15 years.
Dr. Richard Berger, a Zimmer consultant at the time and the lead author of a study concerning the Zimmer product defects, called the failure rate of the Zimmer knee component “horrific.” When Dr. Berger attempted to discuss the matter with Zimmer, he was advised that the unprecedented failure rate was due to physician technique and error, and patient type.
The Zimmer NexGen CR-Flex knee device is a synthetic device used to cap the thigh bone at the knee without the traditional use of cement due to its porous fiber metal and a cobalt-chromium-molybdenum alloy construction.
Zimmer has recalled other knee implant components including a number used with the Zimmer NexGen Complete Knee Solution MIS procedure, such as the NexGen TM Tibial Trays, NexGen MIS Tibial Components, and MIS Modular Tibial Plates and Keels. And, although the Zimmer NexGen MIS tibial component recall involved over 68,000 components, Zimmer never issued a public statement regarding the September 2010 action. Finally, in March 2011, the Zimmer NexGen MIS tibial component recall was added to the U.S. Food & Drug Administration’s (FDA) website.
Problems with the recalled components appeared to be preventing them from fusing to bone. The FDA said it has received 114 reports of complications associated with the recalled Zimmer NexGen MIS tibial components, such as loosening of the device; every on of those patients required revision surgery.
Legal actions also continues to mount against the device maker. Most recently, we reported that another lawsuit was filed against Zimmer Holdings Inc. and its subsidiaries, claiming that the Zimmer NexGen CR-Flex Porous Femoral knee replacement system is defective. The plaintiff in that case, a resident of Illinois, claims his Zimmer NexGen knee failed less than three years after it was implanted.
