DePuy Synthes Knee Implant Class 2 Recall Issued Due to High Revision Rate

DePuy Synthes’ LCS Complete RPS Knee System was recalled 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. The recall was categorized as Class 2, meaning that the device may lead to temporary or medically reversible adverse events. In the United States, DePuy has sold 15,571 LCS Complete RPS femoral implants and 17,732 LCS Complete RPS inserts since 2006.

DePuy Synthes issued a field safety notice in March. The company stated that the recall was issued due to “the potential occurrence of pain when the native patella is not resurfaced” Mass Device reports. “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.

Australian regulators flagged the high revision among these devices. 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.

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