IGMPI India

Zimmer Holdings, Inc. has initiated a voluntary recall of 41,180 stemmed tibial components of the NexGen Complete Knee Solution system.The recall is of various sizes and part of the “NexGen systems of semi-constraint, non-linked condylar knee prosthesis.” Some of the tibial baseplates were made with defective threads in a hole where surgeons screw in a drop-down stem extension or stem plug. If not threaded correctly, the device could loosen and fail.

Zimmer initiated the recall on May19, 2014, after it received 12 complaints in a 2 ½-year period. The U.S. Food and Drug Administration (FDA) announced the recall the following month, and so did the health authorities in Australia. The components were manufactured by Zimmer Manufacturing B.V. in Puerto Rico.The recall is considered a Class 2 recall, indicating the damaged device might cause temporary or serious medical complications.The faulty devices were distributed during a four year period between February, 2010 and May 2014.Over 1,000 lawsuits involving the NexGen are pending against Zimmer in federal court.

The device is commonly used with other Zimmer knee replacement systems like the LPS-Flex and CR-Flex minimally invasive knee replacement devices. Surgeons install the tibial component during minimally invasive knee surgery, which has shorter recovery times, less blood loss and a greater range of motion because of tissue-sparing techniques. They assemble the component once the new knee is put in place. This tends to make the faulty pieces more problematic. The defective device could lead to post-surgery complications like infection, bone loss, surgery, tissue damage, instability, dislocation, etc.