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.
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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…