Another Artificial Knee Component Recall

On September 15, 2010, Zimmer, Inc. sent letters sent to their distributors, sales staff, risk managers and surgeons informing them of a potential problem with a subset of femoral components from the LPS artificial knee line. The Problem: Specific units of the LPS artificial knee femoral component were found to have a nonconforming internal CAM radius. A little background: The LPS knee is a general posterior stabilized design. The LPS design was specificially developed with an integral cam within the femoral component. The cam on the femoral component is designed to engage a post on the tibial plate insert component as the knee flexes. The interaction between the cam on the femoral compent and post on the tibial plate insert provides a functional substitute for the posterior cruciate ligament (PCL). The mechanism provided by the cam and the pst is suppose to help the knee react naturally which results in a femoral rollback as flexion occurs.

One group that did know of the problem was the FDA. Unfortunately, for device recipients and their families, the FDA quietly issued a Class II Recall for this subset of femoral components from the LPS artificial knee line that Zimmer informed its sales people about in September. Even worse, the FDA the did not issue their recall until December 2, 2010. Just as Zimmer had discretely alerted their sales force about the problem, the FDA as well did little to nothing to notify the public of the potential problems with the subset of LPS knees. No press release was made by the FDA regarding the recall; it was simply listed on the FDA’s recall database – to be found only if you were searching for it.

There are two subsets of Zimmer LPS femoral components included in the FDA’s December 2010 Recall:

• NexGen Complete Knee Solution LPS Flex Gender Femoral Component
  • Size E for the RIGHT knee
  • Size E for the LEFT knee
  • Size F for the RIGHT knee
  • Size G for the LEFT knee
• NexGen Complete Knee Solution LPS Femoral Component (n.k.a. LPS Option Femoral Component)
  • Size E for the RIGHT knee
  • Size F for the LEFT knee
  • Size F for the RIGHT knee
  • Size G for the LEFT knee
  • Size G for the RIGHT knee

To the best of this author’s knowledge, Zimmer has never notified its customers or made any type of press release to the general public letting know about this potential device problem despite there being at least 1,500 femoral components in the market that could potentially be affected by the nonconforming and inconsistent geometry in their manufacture.