A lawsuit has been filed against Zimmer Holdings Inc. and its subsidiaries which claims that the Zimmer NexGen CR-Flex Porous Femoral knee replacement system is defective. The plaintiff, a resident of Illinois, claims his Zimmer NexGen knee failed less than three years after it was implanted.
The Zimmer NexGen CR-Flex Porous Femoral Component lawsuit was filed in U.S. District Court, Northern District of Illinois. According to the complaint, the plaintiff received the knee replacement in November 2007. A year later, the plaintiff began experiencing severe pain, and it was eventually determined that the knee replacement was loosening. In March 2010, the plaintiff was forced to undergo revision surgery to have the implant replaced.
Introduced in 2003, Zimmerâ€™s NexGen CR-Flex Porous Femoral Component is a synthetic device used to cap the thigh bone (femur) where it connects with the tibia at the knee. Unlike traditional knee implants, the component is made of a porous fiber metal and a cobalt-chromium-molybdenum alloy and is not attached using cement.
In a filing with the U.S. Securities and Exchange Commission (SEC), Zimmer noted that the NexGen CR-Flex Porous Femoral component was the subject of a study of 108 patients (â€œThe High Failure Rate of a High-Flex Total Knee Arthroplasty Designâ€) by Drs. Richard Berger and Craig Della Valle of Rush University Medical Center. The Zimmer SEC filing states: “According to the published abstract, Drs. Berger and Della Valle revised 9 (8.3%) patients for femoral loosening and pain. The study also reported that 39 (36%) patients showed evidence of radiographic loosening and that â€œ[l]oosening and revision were not related to surgeon, approach or patient type.â€
In their study, which was presented at the March 2010 Annual Meeting of the American Association of Orthopaedic Surgeons, Drs. Berger and Della Valle concluded: “This component is still commercially available but should not be used for any patient,” the study authors wrote.
According to an article published in The New York Times, Zimmer ignored Dr. Berger’s concerns about the NexGen CR-Flex Porous Femoral Component when he raised them with the company, and suggested that his surgical technique was to blame for his patientsâ€™ problems. Zimmer ended its consulting relationship with Dr. Berger shortly after he began criticizing the component, the Times said.
Just last week, we reported that Zimmer had recalled some other components used with the Zimmer NexGen Complete Knee Solution MIS procedure, including NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels. Though the Zimmer NexGen MIS tibial component recall involved more than 68,000 components, Zimmer did not issue any type of public statement regarding the action, which occurred in September 2010. It wasnâ€™t until March 2011 that the Zimmer NexGen MIS tibial component recall was added to the U.S. Food & Drug Administrationâ€™s (FDA) website.
Problems with those recalled components appeared to be preventing them from fusing to bone. According to the FDA, there have been 114 reports of complications associated with the recalled Zimmer NexGen MIS tibial components. The reports involve loosening of the knee replacement, and in all 114 reports, patients required revision surgery.