P.F.C. SIGMA 96-1101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295234876), received between Feb 16, 2023 and Feb 16, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THE PATELLA TRIALS HAD SCORE MARKS ON THEM AS THEY ARE ALL VERY OLD AND USED. THE PROX TIB UPRODS GRUB SCREW ON THE BLACK LEVER KEEPS FALLING OUT AND DOESN¿T HOLD ONTO THE CUTTING BLOCK TIGHT ANYMORE DUE TO IT BEING VERY OLD AND USED/WORN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388919 ↗
• MalfunctionFeb 16, 2023Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THE PATELLA TRIALS HAD SCORE MARKS ON THEM AS THEY ARE ALL VERY OLD AND USED. THE PROX TIB UPRODS GRUB SCREW ON THE BLACK LEVER KEEPS FALLING OUT AND DOESN¿T HOLD ONTO THE CUTTING BLOCK TIGHT ANYMORE DUE TO IT BEING VERY OLD AND USED/WORN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388914 ↗