Zimmer Recalls Products Manufactured in Puerto Rico

Chicago, ILAnother member of the Zimmer NexGen Knee Replacement family of medical devices has reportedly fallen on hard times with the apparent recall of the NexGen MIS Tibial Component, due to reported incidents of loosening or failure of the joint. The allegation surrounds less-than-stellar manufacturing.

Zimmer issued a communiqué to medical professionals and the healthcare industry in order to alert them to a potential problem with some 40,000 devices. This particular Zimmer knee replacement recall surrounds the potential for tibial baseplates to have been manufactured with defective threads in an opening whereby surgeons fasten either a stem plug or a drop-down stem extension.

If the threading of the plug or stem extension is compromised due to the possibility, in Zimmer’s words, that the component is “out of specification,” the device could loosen or fail altogether, posing Zimmer knee replacement problems for the patient involved.

Zimmer says units affected by the manufacturing problem total 41,180 and were distributed to surgeons and hospitals over a four-year period between February 2010 and May 2014. It was in late spring when this latest Zimmer knee implant recall - a voluntary recall by Zimmer - was issued.

The Zimmer knee replacement recall was issued by way of a letter to medical professionals and the healthcare community on June 10 of this year, and is identified as a Class 2 recall. Not the most serious, but nonetheless of sufficient concern to potentially cause temporary or serious medical complications.

One of the concerns for patients requiring revision surgery is if the original component is cemented to the bone. The resulting bone loss inherent with the revision procedure could translate to a negative impact on the patient going forward.

This particular Zimmer Knee Replacement recall is reminiscent of a previous recall in the spring of 2010, when Zimmer issued a previous urgent device correction letter. The US Food and Drug Administration (FDA) soon issued a Class 2 recall after receiving over a hundred complaints from Zimmer NexGen Knee Replacement patients. That recall affected 68,383 devices and stemmed many a NexGen lawsuit. To that end, lawsuits have been consolidated in the Zimmer NexGen MDL multidistrict litigation in US District Court in Illinois, with the first trial scheduled before US District Court Judge Rebecca Pallmeyer for February 2015.

This most recent Zimmer NexGen Knee recall involved devices manufactured in Ponce, Puerto Rico - and is indicative of the reality that manufacturers are increasingly moving manufacturing offshore, in an effort to reduce manufacturing costs. Patients, it appears, are paying the price…