Zimmer NexGen Recall

While there are some restrictions in movement, knee replacement systems or artificial knees can help a person regain strength and control over their mobility. Knee implant components are intricate, which require an acute attention to detail by artificial knee manufacturers when designing, testing, and creating these medical devices.

A widely implanted knee replacement system, Zimmer NexGen CR-Flex, has been reportedly failing at significant rates. The implant was designed to give patients a better range of motion than the customary NexGen device. However, some patients who have received a Zimmer knee implant have reported experiencing excessive pain, device failure, loosening of implant parts, and a need for revision surgery.

Zimmer NexGen CR-Flex Artificial Knee Rejection

Even though an official recall for the Zimmer NexGen CR-Flex knee implant system has yet to be announced, Dr. Richard A. Berger, who worked on designing surgical tools and artificial joints for orthopedic implant maker Zimmer Holdings, has gone public with a study that he claims proves the artificial-knee models are failing prematurely. Dr. Berger implanted the Zimmer artificial knee in about 125 patients in 2005 with the intention that they would last approximately 15 years. However, Dr. Berger has stated that by early 2006, some X-rays revealed that the knee devices were loose and had not fused completely to the thigh bone as intended.

Dr. Berger performed a study on the devices with Dr. Craig J. Della Valle, who was also encountering patients with Zimmer knee replacement problems that led to knee implant revision surgery. Their results reveal that Zimmer NexGen CR-Flex knee implant systems failed early in approximately 9 percent of some 100 patients evaluated. Moreover, the knee implant displayed signs of looseness in about half of all patients, and has since been replaced in some of them.

History of Knee Implant Failure

In September of 2010, NexGen complete knee solution MIS tibial components, locking screw and stem extensions were recalled after Zimmer received complaints of loosening of the implanted device. According to the FDA recall announcement, 114 MDRs were filed, all reporting that the device loosened and the patient required additional surgery to replace the device.

In spite of this previous Zimmer knee implant device recall, the FDA did not require Zimmer to evaluate the NexGen CR-Flex knee implant device in patients before selling it to be used as artificial knee implants. While this may seem surprising, a substantial amount of artificial joints are legally cleared by the FDA for sale without requiring patient testing. Perhaps part of the problem with inefficient artificial knee implants is that tracking of long-term performance of these devices is not required by law.

Zimmer Knee Replacement Attorney

Orthopedic implant safety is of great importance. Patients undergoing knee replacement surgery have every right to assume that the artificial knee implant they receive is safe and efficient. If you or someone you care about has experienced Zimmer NexGen CR-Flex knee implant failure or rejection, thus requiring replacement surgery, there may be an opportunity to obtain compensation from the manufacturers of the device. At Anapol Schwartz, our Zimmer knee implant failure attorneys are prepared to evaluate the specifics of your situation and build a strong case on your behalf. Contact us today for more information.

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