P.F.C. SIGMA 96-1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295234845), received between Oct 13, 2017 and Apr 10, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. A. WHAT IS THE EVENT DATE? AS I SAID, IN MY ORIGINAL COMPLAINT. ¿THERE HAVE RECENTLY BEEN A NUMBER OF THEIR CONSIGNED INSTRUMENT TRAYS TAKEN OUT OF CIRCULATION, DUE TO BROKEN OR DAMAGED INSTRUMENTS. THE BROKEN OR DAMAGED INSTRUMENTS HAVE BEEN DISPOSED OF EITHER IN THEATRES OR IN CSSD. AND THE TRAYS SET ASIDE. SO I DON¿T HAVE ANY DETAILS ON WHAT HAPPENED WITH ANY OF THEM, OTHER THAN THEY WERE DAMAGED OR BROKEN IN THE COURSE OF NORMAL USE¿. THESE TRAYS WERE TAKEN OUT OF CIRCULATION BY THE HOSPITAL, NOT BY ME. SO, I DON¿T HAVE ANY INFORMATION AS TO WHEN THEY DID SO. THERE ARE MULTIPLE TRAYS. AND THEREFORE, PROBABLY MULTIPLE EVENT DATES. BUT, NONE OF THE DATES HAVE BEEN RECORDED BY THE HOSPITAL. B. PLEASE CLARIFY, WHAT YOU MEAN BY DAMAGED? IS IT BROKEN INTO TWO PIECES, DULL, BENT, CRACKED, STRIPPED, WORN, SCRATCHED, CROSS THREADED OR ANY DEVICE INTERACTION ISSUES? AGAIN, I DON¿T HAVE ANY INFORMATION ON THIS. BUT, I CAN SPECULATE, THAT THE DRILLS PROBABLY GOT BLUNT OR BROKE. THE TIBIAL IMPACTORS PROBABLY BROKE INTO 2 PIECES (WE¿VE HAD MANY OF THESE BREAK IN HALF WHEN THEY GET OLD). THE POLY INSERT IMPACTOR PROBABLY CRACKED AS IT IS PLASTIC AND THE 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080203 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315779 ↗
• 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 16388950 ↗
• 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 16388929 ↗
• 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 16388899 ↗
• MalfunctionNov 23, 2022Break; Break

  INSTRUMENT BROKE DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850761 ↗
• MalfunctionMay 26, 2022Break; Break

  IT WAS REPORTED THAT ONE OF THE 3 POSTS THAT SITS IN THE PATELLA WHEN TRIALING HAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515612 ↗
• MalfunctionMar 8, 2022Material Twisted/Bent; Naturally Worn; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED AS WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692848 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT THE PEG BROKE OFF OF THE PATELLA TRIAL. ALL PIECES WERE REMOVED, NO ADDITIONAL SURGERY TIME REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897346 ↗
• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED THAT ONE OF THE PEGS BROKE OFF OF THE PATELLA TRIAL. THE PEG WAS REMOVED FROM THE BODY BUT DISCARDED IN THE TRASH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9175371 ↗
• MalfunctionOct 13, 2017Break; Break

  IT WAS REPORTED THAT THE SIGMA 32 OVAL DOME PATELLA POSTS HAVE BEEN BROKEN OFF AND NEED TO BE REPLACED.

  Patient problems: No Information

  MAUDE report 6949023 ↗