The NexGen CR-Flex system 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 is made of a porous fiber metal and a cobalt-chromium-molybdenum alloy and is not attached using cement.
Zimmer Holdings, Inc. introduced the NexGen CR-Flex Knee Replacement Implant in 2003, touting it as a dynamic new device that would provide “a greater range of motion for patients”. Unfortunately, since that time, numerous patients have experienced problems with the knee replacement implant, up to and including early failure of the knee replacement device.
Since it was brought to market, more than 150,000 of these implants have been sold, and new data suggests that while they were originally projected to last around 15 years, a large percentage of the devices have failed in three years or less. The main problem that has been reported with the NexGen concerns the fact that its “high-flex” component is not surgically cemented to the bottom of the patient’s thigh bone. Most knee replacement devices are secured with surgical cement to prevent loosening, which may explain the NexGen’s inexcusably high failure rate.
After encountering problems with the device in some of his patients, Dr. Richard A. Berger, a consultant to Zimmer, approached the company with his concerns. Zimmer did not react favorably to Dr. Berger’s assertions, and blamed his surgical technique for the failures he had observed. [Dr. Berger’s contract with Zimmer was not renewed.] This course of action was contradictory to an earlier Zimmer marketing campaign which had actually praised Dr. Berger’s minimally invasive surgical techniques.
The problem with the device, according to Berger, was that the “Uncemented” NexGen CR-Flex Porous Femoral Component (a model that relies on bone in-growth rather than bone cement to attach) was not properly adhering to patients’ thigh bones, resulting in loosening, pain, and in some cases, failure of the device.
These actions by Zimmer prompted the former consultant, to, along with fellow ‘Rush University Medical Center’ colleague, Dr. Craig J. Della Valle, evaluate some 108 patients with the Zimmer NexGen CR-Flex Knee Replacement device. Presenting their results at the American Academy of Orthopedic Surgeons Meeting in the fall of 2009, the two revealed that, according to their research, thirty-five percent (35%) of NexGen patients examined after two years showed signs and symptoms of loosening of the replacement device, and that nearly nine percent (9%) of patients examined after the same time period, required revision knee surgery due to loosening and pain.
Knee replacement surgery is, in and of itself, an extremely painful ordeal. The notion that patients should have to experience addition pain and suffering, along with costly and potentially damaging revision surgery because of a faulty medical device is unacceptable.
If you or someone you know has suffered because of complications caused by the Zimmer, Inc. NexGen CR-Flex knee implant device, you have valuable rights. Let the experienced team of personal injury lawyers at Sullo & Sullo, LLP represent you and fight for the full and fair compensation you deserve. Call us today at 1-800-730-7607 or visit our FAQ page to learn more about the lawsuit and your many options.
Please read on to learn more about the Zimmer NexGen CR-Flex Knee Replacement Recall and how to protect your rights.