About the NexGen Knee Recall Tibial Plate

Zimmer Holding, Inc., is the manufacturer of NexGen CR-Flex Porous knee replacement system. This company has recently come under fire because of problems that have arisen with regard to these implant devices. This device was designed to adhere to the patient’s bone without the use of adhesive cement, which is traditionally used in knee replacement devices. This knee implant affixes to the femur or tibia, using a cobalt chromium molybdenum alloy and metal fiber that was supposed to mimic human bone material. It appears that the tibial plate portion of the implant, that should be affixed to the thighbone, becomes loose causing a myriad of problems. In September of 2010, the tibial component of this knee implant was recalled.





These problems may go back to 2006, when a surgeon consultant for Zimmer, Dr. Richard Berger reported concerns over the device’s failure rate. Zimmer responded by saying that the failure rate was due to the surgeons technique in implanting the devices. Dr. Berger joined forces with a co-worker, Dr. Craig J. Della Valle who was also noticing problems with the implant devices. The doctors later released information that demonstrated the particular problems with this implant. In this report, Dr. Berger used the implant device in 125 patients. While the device was expected to last up to 15 years, a number of replacement devices were failing within one year. In fact, 9.3% of the devices failed within two years, and 36% of the patients were experiencing loosening of the implant. Over ½ of the original 100 patients experienced other side effects. Pursuant to their findings, the doctors concluded that "this component is still commercially available but should not be used for any patient." There are other studies and reports that contradict the findings of these doctors and the overwhelming majority of patients with the Zimmer knee have not experienced any problems.





Potential side effects of these devices include loosening of the device, persistent pain and inflammation, infection, blood clots, dislocation and complete failure of the implant.





In September of 2010, the FDA issued a Class 2 recall of certain component parts of the NexGen Complete Knee Solution MS. This device is commonly recommended for patients that have trauma, arthritis and other deformities. Since the release of the device on the market in 2003, over 150,000 knee implants have been sold.





Symptoms of knee implant failure can include:





Difficulty performing weight bearing activity;





Persistent knee pain;





Stiffness;





Inflammation;





Decreased range of motion.





So far, the reasons for these problems are unknown. Currently, the Zimmer NexGen recall deals with the tibial plate portion of the replacement device, although other problems are being reported. If you have received a Zimmer knee replacement device and are experiencing symptoms of loosening or failure, it is important to speak with a lawyer handling Zimmer NexGen knee lawsuit clailms for more information. They will provide you with legal guidance as well as a free consultation. Should you decide to take legal action, they will take your cases on a contingency basis. This means that you will pay nothing unless we will your case.