P.F.C. SIGMA 96-1102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295234890), received between Oct 5, 2017 and Feb 9, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2023Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THE PATELLA TRIAL WAS WORN WITH SCUFFS. THE TRIAL TRAY PIN HOLES WERE WORN MAKING IT DIFFICULT TO PIN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335555 ↗
• MalfunctionApr 25, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SIGMA 38MM OVAL PATELLA TRIAL IS WORN OUT AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194746 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT THE PRODUCT FROM THE LOAN KIT WAS ARRIVED AT THE HOSPITAL BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938245 ↗
• MalfunctionDec 29, 2021Break; Break

  BROKEN DUE TO FAIR WEAR AND TEAR. EMAIL RESPONSE - WHAT PART OF THE PFCSIG OV/DOMPAT 3PEG TRL38MM BROKE?ONE OF THE PEGS DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED OR CROSS THREADED? PEG BROKE OFF. PLEASE PROVIDE VALID LOT NUMBER FOR PFCSIG OV/DOMPAT 3PEG TRL38MM (961102). UNAVAILABLE PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY? IF YES, WAS THERE SURGICAL DELAY? YES AND YES. WHAT WAS THE DURATION OF THE DELAY? 5 MINS WHILST THEY OPENED ANOTHER PATELLA INSTRUMENT TRAY.

  Patient problems: Insufficient Information

  MAUDE report 13109070 ↗
• MalfunctionOct 23, 2020Break; Break

  THE PART WAS REPORTED AS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726981 ↗
• MalfunctionJul 22, 2020Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE LUG DRILL IS DULLED AND NOT CUTTING PATELLA TRIAL IS MISSING A PEG THAT SHEARED OFF. THE SIZE POLY TRIALS ARE FADED AND SIZES AREN¿T ABLE TO BE READ OR DISTINGUISHED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308848 ↗
• MalfunctionSep 19, 2019Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THERE WAS A MISSING PEG FROM PATELLA TRIAL. DID NOT IMPACT CASE. PEG GOT THROWN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087645 ↗
• MalfunctionOct 5, 2017Break; Break

  DER STATES THAT DURING THE REVISION SURGERY, THE SURGEON REMOVED THE ATTUNE PATELLA AND HE WAS ATTEMPTING TO PUT THE NEW SIGMA PATELLA TRIAL ON THE BONE. IT WOULDN'T GO DOWN, SO THE SURGEON USED THE PATELLA CLAMP TO PUT PRESSURE ON THE PATELLA TRIAL. ONE OF THE POSTS OF THE 38 MM SIGMA PATELLA 3 PEG TRIAL BROKE OFF. THE PIECE OF THE PATELLA PEG TRIAL WAS RETRIEVED AND REMOVED FROM THE WOUND.

  Patient problems: No Information

  MAUDE report 6914796 ↗