A preliminary agreement has been reached to settle lawsuits involving problems with certain Zimmer NexGen implants. Lead counsel in the multidistrict litigation (MDL) against Zimmer NexGen reportedly told an Illinois federal judge that they reached a tentative agreement.
If the confidential settlement is approved, it could potentially resolve all MDL cases filed in the court as of January 15th, roughly 300 cases, as well as similar cases pending in state courts.
The U.S. Food & Drug Administration, in 2010, issued a Class II recall to Zimmer Inc. over the NexGen Complete Knee Solution, affecting 68,383 devices already implanted. An FDA Class II recall typically indicates a device may cause “temporary or medically reversible” health problems, and potentially serious health problems.
In addition to the FDA recall, Zimmer made a voluntary recall regarding the NexGen MIS Tibial Component, because according to drug watch, “one of the pieces could loosen or fail because of shoddy manufacturing.” The voluntary recall affects 41,180 devices.