SIGMA 86-6498Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295217190), received between Sep 12, 2019 and Sep 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2019Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth

  CLINICAL ADVERSE EVENT RECEIVED FOR GROSSLY LOOSE TIBIA, FEMUR IS INTACT AND WELL INGROWN : MIGRATION / LOOSENING - TIBIAL. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO PROCEDURE. DATE OF REVISION #1: (B)(6) 2011. DATE OF REVISION #2: (B)(6) 2012. DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Inadequate Osseointegration; No Consequences Or Impact To Patient; Pain

  MAUDE report 9011631 ↗