Zimmer Inc.’s NexGen CR-Flex Porous Femoral Component may be associated with a substantially higher-than-expected failure rate. Knee replacements should last around 15 years, but some evidence suggests that patients with a Zimmer NexGen CR-Flex Porous Femoral Component may experience failure of their knee replacement in three years or less.
Lawyers at our firm are currently evaluating potential lawsuits on behalf of people injured by the Zimmer NexGen CR-Flex Porous Femoral Component. If you have experienced unexplained pain or discomfort after knee replacement, loosening of replacement knee, a loose feeling in the replacement joint, difficulty walking, or have undergone revision knee surgery to correct problems with a NexGen CR-Flex Porous Femoral Component, we want to hear from you today.
Our Zimmer NexGen CR-Flex Porous Femoral Component lawyers are offering free legal consultations to anyone injured by this medical device. If your knee replacement failed prematurely, and your received a NexGen CR-Flex Porous Femoral Component, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. We urge you to contact one of our Zimmer NexGen CR-Flex Porous Femoral Component lawyers today to protect your legal rights.
Zimmer NexGen CR-Flex Porous Femoral Component Failures
Introduced in 2003, Zimmer’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 CR-Flex Porous Femoral 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 (“The High Failure Rate of a High-Flex Total Knee Arthroplasty Design”) 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 “[l]oosening and revision were not related to surgeon, approach or patient type.”
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 Zimmer’s SEC filing, since being brought to market, more than 150,000 NexGen CR and NexGen CR-Flex Porous Femoral components have been sold. According to the Australian National Joint Replacement Registry, since 2004, revision surgery was reported for 120 patients implanted with one of these components.
According to a New York Times article published in June 2010, Dr. Berger, a former Zimmer consultant, claims the when he expressed concern to the company about the component, Zimmer officials “claimed that the problem was not the artificial knee, but his technique, and pointed to data overseas indicating that the knee was safe.” Dr. Berger told the Times he stopped using the device in 2007, and had learned that several other surgeons had experienced problems with it. In 2009, Zimmer declined to renew its consulting contract it with Dr. Berger.