Zimmer Recalled NexGen MIS, NexGen LPS Knee Replacement Components in 2010Apr 28, 2011 | Parker Waichman LLP
Unbeknownst to many consumers, Zimmer Inc. has quietly issued recalls for components used in a couple of its NexGen knee replacement systems. In one of those recalls, which involved tibial components for use in the NexGen Complete Knee Solution MIS system, more than 100 patients reported loosening of their knee replacements and had to undergo revision surgery because of those problems.
The NexGen MIS tibial component recall was issued on September 15, 2010, but the U.S. Food & Drug Administration (FDA) database was not updated with information about this action until last month. The other recall, which involved Zimmer NexGen LPS femoral components, was issued on September 13, 2010, but information about that recall did not appear in the FDA database until December 2010.
The Zimmer NexGen MIS tibial component recall involved more than 68,000 NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
Problems with the components appeared to be preventing them from fusing to bone. In an April 2010 “Urgent Device Correction" letter, surgeons were instructed to use a modified surgical technique when implanting the affected components. In all, 114 patients had to undergo knee replacement revision surgery due to these defective Zimmer components.
The Zimmer NexGen LPS femoral component recall involved 158 flex gender femoral components (recall #Z-0534-2011) and 192 femoral components (recall #Z-0528-2011) of various sizes. These recalls were issued because some of the devices were found to have nonconforming and inconsistent geometry. According to the recall notices for these actions, surgeons were informed of the issue but there was no action to be taken by surgeons.
It does not appear that either Zimmer or the FDA took any steps, such as issuing a press release, to inform patients or the public of these knee replacement component recalls.