July 23, 2014 — Zimmer is recalling 41,180 stemmed tibial components of the NexGen Complete Knee Solution due to a problem that could lead to infection, bone loss, dislocation of the knee, and early revision surgery.
The Class II recall was initiated by Zimmer in May and announced by the U.S. Food and Drug Administration (FDA) in an enforcement report on June 9.
The problem is that the tibial baseplate component was manufactured with defective threads in a hole where surgeons are supposed to screw in a drop-down stem extension or stem plug. If the stem extension does not seat properly on the baseplate, dislocation may occur.
This could lead to a number of painful and debilitating complications, including:
- Loosening: If the components do not lock together, the knee may be loose and unstable, which increases the risk of dislocation and bone fractures.
- Infection: A dislocated knee can cause serious tissue damage that can lead to infection.
- Revision surgery: A defective knee implant typically must be removed and replaced — a painful, expensive, and time-consuming process.
- Bone loss: If the original knee implant was cemented in place, doctors may need to remove bone to install a new implant.
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