Consumer Drug Safety

Trials Underway Concerning Zimmer’s NexGen Knee Replacement Devices

The bellwether trial concerning the NexGen knee implant that began in mid-October recently wrapped up with a verdict favoring the implant’s manufacturer. The plaintiff in the case suffered from degenerative joint disease and underwent total knee replacement on both knees in 2009. After receiving the NexGen Flex system, she began experiencing pain and replaced her implants in 2011.

It was considered one of the strongest cases against Zimmer. NexGen is manufactured by the Zimmer medical company and was approved for use by the FDA in 1995.

Zimmer released the High Flex NexGen knee implant in 2001, which is an updated version of the original NexGen. The new device was supposed to provide users with a wide range of motion, but many now claim it was defective and caused them pain after the device loosened or failed and required follow-up revision surgery to correct the problem. The updated device was received approval through the 510K fast-track approval system that allows products to be released to the market without investigation and testing if it is similar to a product already approved.

There are several thousand complaints about NexGen knee replacement devices and more than a thousand cases pending in multi-district litigation in the Norther District of Illinois. Upcoming bellwether trials including the most recent one will be used to give plaintiffs and attorneys a clear indication how juries will respond to evidence and claims that are similar in all of the trials, so they can then determine how to proceed.

Adverse Events Include Many Zimmer Knee Replacement Devices

Zimmer’s product line includes a variety of surgical products and artificial joint replacement devices. It is the largest producer of knee implants in the world, controlling more than a quarter of the market. The NexGen knee replacement is considered one of its most successful products since its release in 1995.

The modified version of the NexGen, the NexGen Flex, was designed to offer 155 degrees of rotation. Unfortunately, not long after its release, adverse event reports began rolling into the FDA and the company was targeted in four product recalls ordered by the agency. These recalls included the NexGen Complete Knee Solution MIS Tibial Components, the MIS Modular Tibial Plats and Keels, and the NexGen TM Tibial Trays in the fall of 2010, and the NexGen LPS-Flex Gender Femoral Component later that year.

In 2012, the FDA issued a Class II Recall concerning Zimmer’s Natural-Knee II Durasul All-Poly Patella and then in 2015, another recall was issued for the Persona Trabecular Metal Tibial Plate.

More than 1000 lawsuits were filed following the recalls.

Problems with the Zimmer Devices Cause Pain and Need for Revision Surgery

Adverse event reports include claims that components from the joint replacement devices loosen and trigger radiolucent lines, which are gaps between the replacement device and the bone, or between components. The gaps can cause buildup of joint fluid, debris or tissue, which eventually leads to osteolysis and a loosening of the implant. When this occurs, there will be eventual failure and a need to repair or replace device components, which requires at least one additional surgery.

Revision surgery also leaves a person at a greater risk for bone fracture, and in an overall weakened state. Recovery from revision surgery, when complete recovery is even possible, is long and difficult for many patients.

Source:

  • http://www.reuters.com/article/2015/11/06/zimmer-biomet-nexgen-idUSL1N1312VM20151106