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 survivorship pursuant to the acceptance criteria for the [device performance review] protocol for the ATN system.”
The issue could lead to “secondary reduction loss or lateral sliding of the screw resulting in a revision surgery” and “screw cut-out resulting in a total hip arthroplasty or revision surgery,” the company said.