Revision rates prompt recalls for Johnson & Johnson ’ s DePuy Synthes, Zimmer Biomet

High revision rates for orthopedic implants prompted recalls in recent months for Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes and Zimmer Biomet (NYSE:ZBH).
Last month DePuy Synthes recalled a stand-alone element of its Sigma HP partial knee replacement, the Sigma HP PFJ cemented trochlear implant, “based on elevated revision rates observed as part of the company’s post-market surveillance process.” No other Sigma HP implant or total knee is implicated in the recall, J&J said.
“Further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. The company recommends that surgeons use alternative implants or consider a total knee replacement,” the company said in a field safety notice dated December 2017. “The possible clinical implications related to the affected Sigma HP PFJ cemented trochlear implants include poor joint mechanics (malalignment, instability, and/or dislocation/subluxation). The clinical implications above may potentially require revision surgery.”
J&J said it’s distributed roughly 7,500 of the devices worldwide since 2006.
Zimmer Biomet’s recall involves a product formerly distributed by DePuy, the Ace trochanteric nail system for treating femoral fractures, sent out between July 2012 and December 2017. In a Jan. 15 field safety notice, the Warsaw, Ind.-based orthopedics giant said the device “failed clinical analysis for surviv...

Source: Mass Device - January 17, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Orthopedics Recalls Regulatory/Compliance depuysynthes johnsonandjohnson zimmerbiomet Source Type: news