Zimmer Nexgen Knee Implant Ban Pending in U.K., Due to High Failure Rate

Zimmer Nexgen knee replacement implants had double the acceptable failure rate, with 7% failing within 10 years due to aseptic loosening.

Medical device regulators in the United Kingdom are expected to announce a ban on Zimmer Nexgen knee replacement implants, following high failure rates experienced by patients, which led to a recall in October.

Various media reports indicate the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) will issue a ban this week, following reports of more than 350 Zimmer Nexgen knee implant failures.

The Zimmer NexGen system was first introduced in 1995, with most components later approved in the United States without extensive trials or FDA investigation into their safety through the 510K fast-track approval program, which only requires that devices be “substantially equivalent” to medical devices already on the market to obtain marketing approval.

At one point, Zimmer Biomet faced nearly 1,300 product liability lawsuits in the U.S. federal court system, each involving similar allegations that certain Zimmer NexGen components were defective and failed prematurely.

In February 2018, a global Zimmer NexGen knee settlement was announced, after an agreement was reached in principal to resolve all state and federal cases in the U.S.

On December 6, several U.K. media outlets reported that officials from MHRA told them they plan to announce a ban on Zimmer Nexgen knee implants next week. The announcement comes after the U.K.’s National Joint Registry reported the knee replacement implants had twice the failure rate deemed acceptable by U.K. medical device regulators.

The report found more than 10,000 patients there had been implanted with the Zimmer Nexgen implants, with 350 experiencing implant failures, requiring additional or revision surgeries within 10 years due to aseptic loosening.

According to the National Joint Registry, the Zimmer knee implants had a failure rate of about seven percent, which is twice the acceptable failure rate.

Officials from Zimmer, which still sells NexGen knee implants in the U.S., said they will put up information on what it is calling a voluntary recall on its website once the ban is officially announced.