Zimmer NexGen Component Recall
The Zimmer NexGen MIS tibial component recall affected 68,384 knee components, which were distributed in 13 states across the U.S. It is unclear just how many of those components were implanted in patients at the time of the recall.
Complications associated with the recalled Zimmer NexGen MIS tibial components include:
- Knee Replacement Failure
- Revision or Replacement of Artificial Knee Device
- Knee and Joint Pain
- Difficulty Standing or Walking
- Decreased Range of Motion
- Soreness or Stiffness
In April 2010, Zimmer warned its customers via an “Urgent Device Correction” letter about complications involving the NexGen MIS Tibial knee components, and instructed medical professionals to use a modified surgical technique when implanting the affected device. The company issued the modified surgical instructions in response to dozens of reports of component loosening and device failure.
On September 13, 2010, Zimmer issued a recall for the NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels, according to information in a Food & Drug Administration (FDA) medical device recall database. However, no public alert was issued by the FDA or Zimmer. Information about the Zimmer NexGen MIS tibial component recall was not added to the FDA website until March 28, 2011.
According to the FDA database, there have been 114 reports of complications associated with the recalled Zimmer NexGen MIS tibial components. Problems included reports that the Zimmer NexGen knees had loosened and that patients had to undergo additional knee surgery to have the devices replaced. All 114 cases required revision surgery.
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