Use:  Used in knee joint reconstruction.

Issue:  Breakdown of metallic surfaces and abnormal wear.  Implants loosening and patients have to go through additional operations.

FDA Action/Recommendation: In 2008, adverse event reports began to surface in the FDA’s database of knee pain, indications of polyethylene wear, and variances in the sizes of implant components.  In June 2009, the FDA announced a Class 2 recall of the Zimmer NexGen Legacy (LSD) knee. Class 2 recalls indicate that a medical device is “potentially dangerous.”

Company: Zimmerman