Class 2 Recall Issued for DePuy Synthes Knee Implant

A Class 2 recall has been issued for DePuy Synthes’ LCS Complete RPS Knee System due to ” higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants” according to the U.S. Food and Drug Administration (FDA) website. When a class 2 recall is issued, it means that the device may lead to temporary or medically reversible adverse events.

In March DePuy Synthes issued a field safety notice indicating “the potential occurrence of pain when the native patella is not resurfaced” according to Mass Device. “When using the LCS Complete RPS Knee System, the patella must be resurfaced. Failure to resurface the patella has been associated with a higher incidence of postoperative patello-femoral pain potentially leading to a secondary procedure,” the notice read.

The higher revision rates were flagged by Australian regulators. Data from the Australian Orthopaedic Assn.’s National Joint Replacement Registry showed a 3.6 revision rate at 1 year for the LCS Complete RPS compaered to 0.3% with patella resurfacing. With no resurfacing, the revision rate increased to 12.9 percent at four years compared to 3.3 percent with patellar resurfacing.

In the United States, DePuy has sold 15,571 LCS Complete RPS femoral implants and 17,732 LCS Complete RPS inserts since 2006.

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.