Orthopedic giant Zimmer (NYSE:ZMH) is pulling components of its NexGen CR Complete Knee Systems off of the Australian market in order to update their labeling in light of some compatibility issues arising among surgeons.
Zimmer in March 2012 issued a warning asking surgeons to be aware that they implant the devices only in combinations approved on the labeling, in order to avoid putting together systems with incompatible pieces. The company has been monitoring the issue since then, finding that there were fewer issues but that the problem was not entirely resolved.
In particular, surgeons have been using the CR micro articular surface in combination with the CR standard femur, according to the Zimmer “urgent medical device removal” advisory.
The medical device maker issued a new letter to surgeons, asking that they ensure they’re using the right pieces when implanting the knee system. Risks of non-compatible combinations include long-term pain and instability due to an imbalanced knee, long-term risk of increased wear that may eventually require revision surgery or decreased range of motion, according to the Dept. of Health & Ageing’s Therapeutic Good administration.
Zimmer is pulling back the devices until it can relabel them, at which point the micro implants will be back on the market.