Zimmer Lawsuit Knee
Zimmer Inc. is one of the largest joint implant manufacturers in the world. They develop and sell a range of prostheses designed to replace the knee joint. Unfortunately, a few have caused complications, including pain and loosening of the implant. Because of the company’s stable of products, there has been confusion surrounding the possibility of a more general Zimmer NexGen recall. If you have suffered from a NexGen knee failure please contact us for the latest Zimmer lawsuit knee news and information.
Some people have come to believe that all artificial knee implants sold by Zimmer are defective, and likely to fail. This has not been proven to be the case. Nor have there been studies suggesting as much. Most of the criticism directed as Zimmer Orthopaedics involves a particular component included with one of their knee replacement systems. To date, there has not been a Zimmer knee recall addressing this component.
Below, we’ll describe the current limited NexGen recall, and explain the reason it was issued in 2010. We’ll then take a look at the controversy focused on the NexGen CR-Flex femoral component.
The Current FDA Class 2 NexGen Knee Recall
On April 26, 2010, Zimmer Inc. sent an “Urgent Device Correction” letter to orthopedic surgeons. The letter instructed them to abandon previous implantation methods they had used to place the tibial component of the NexGen MIS knee implants. The company advised orthopedists to fixate the tibial trays and plates with surgical cement. It also strongly suggested that the components include the stem extension, which is designed to be inserted into the top of the tibia.
On September 30, 2010, the Food and Drug Administration (FDA) issued a Class 2 recall of these components. The agency had received over 100 complaints of loosening in the joint, a complication that required revision surgery to correct.
This recall did not implicate any of the other prostheses made by the joint manufacturer. Nor did it involve the femoral or patellar components. The action was limited to the NexGen MIS tibial pieces, which, according to the FDA, involved 68,384 products. The current controversy aimed at the joint manufacturer is likely to have a wider reach.
Controversy Surrounding The Zimmer NexGen CR-Flex
The NexGen CR-Flex Fixed Bearing Knee system is designed for patients whose bone stock remains strong. Rather than being implanted with surgical cement, the prosthesis relies on natural bone ingrowth. The femoral component is made of a porous material to which bone can adhere. Over time, bony ingrowth fuses with the femoral piece, providing stability for the implant.
In March 2010, a study was released by a respected orthopedist named Dr. Richard Berger. He had coauthored the study with his colleague, another orthopedist named Dr. Craig Della Valle. They evaluated 108 patients who had received the Zimmer NexGen CR-Flex knee replacement systems. Drs. Berger and Della Valle found that nearly 9 percent needed revision surgery due to complications stemming from their prostheses. In addition, they discovered that 36 percent of the patients showed signs of loosening in the knee joint.
This study was released at a conference for the American Association of Orthopaedic Surgeons (AAOS). Both doctors commented that even though the CR-Flex is still sold in the U.S., it “should not be used for any patient.” Since the release of the study, many orthopedists have abandoned the knee replacement systems.
The cause of the high NexGen knee failure rate is still unknown. Some critics suspect the issue is due to its design. Zimmer Inc. has responded by saying the premature failure of the CR-Flex is due to the implantation methods used by orthopedists. The company also claims that poor candidate selection is a factor. These allegations appear disingenuous given the experience and level of expertise of the surgeons.
Despite a number of complaints, the CR-Flex femoral component is still sold in the U.S. A Zimmer knee recall has not yet been issued for this piece. If you have received a Zimmer knee implant, and are suffering from knee pain, loosening of the joint, or other side effects, learn about your legal rights.
We represent all patients affected by the tibial plate Zimmer NexGen recall on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free or fill out our short online contact form and a Zimmer lawsuit knee attorney will contact you to answer any of your questions.