SIGMA 1024-51-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295002314), received between Oct 20, 2017 and Apr 22, 2022 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TIBIAL PLATEAU FRACTURE INTRO-OP. IT WAS REPORTED THAT PATIENT UNDERWENT A MEDIAL PLATEAU TIBIAL FRACTURE WHEN THE TIBIAL WAS ASSEMBLED DURING THE LEFT MEDIAL COMPARTMENTAL ARTHROPLASTY. THEN SURGEON IMPLANTED TWO SCREWS TO SUPPORT THE FIXATION. THE PATIENT HAS NOT YET RECOVERED. DOE: (B)(6) 2022.

  Patient problems: Bone Fracture(s)

  MAUDE report 14186317 ↗
• InjuryDec 26, 2018Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT A LOOSENING OF AN UNICOMPARTMENTAL KNEE PROSTHESIS OCCURED.

  Patient problems: No Code Available; Pain

  MAUDE report 8196060 ↗
• InjuryOct 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS LEFT MEDIAL PROXIMAL TIBIA COLLAPSE.

  Patient problems: No Code Available

  MAUDE report 6965326 ↗