P.F.C. SIGMA 96-1004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295234586), received between Feb 28, 2018 and Sep 12, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2023Naturally Worn; Naturally Worn

  THE GRUB SCREW THAT IS USED TO ATTACHED THE BOX TRIAL TO THE FEMORAL TRIAL HAS ¿ROUNDED OFF¿ SO ITS NOT POSSIBLE TO LOOSEN THE BOX TRIAL FROM THE FEMORAL TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733729 ↗
• MalfunctionNov 15, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE BOX TRIAL SCREW IS STRIPPED, CANNOT DISENGAGE FROM FEMUR TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796805 ↗
• MalfunctionJul 19, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE BOX WAS CROSS THREADED INTO A 4 LEFT SIGMA POSTERIOR STABILIZED FEMUR TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051452 ↗
• MalfunctionMar 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE FEMORAL TRIAL HAD BEEN USED PREVIOUSLY ON NUMEROUS OCCASIONS, HOWEVER, THE FEMORAL TRIAL FIRST WELL ON THE CUT SURFACES. THERE WAS A 20-MINUTE SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9856232 ↗
• MalfunctionJul 3, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SIZE 4 SIGMA NOTCH TRIAL IS STUCK IN THE SIZE 4 (LEFT) SIGMA FEMORAL COMPONENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757642 ↗
• MalfunctionMar 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER´S CSSD IS COMPLAINING THE TRIALS NOT TO BE MARKED/ETCHED WITH AN ARTICLE NUMBER / REF NUMBER. SO IT IS NOT POSSIBLE TO IDENTIFY/CATEGORISE THE MEDICAL DEVICE. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463768 ↗
• MalfunctionNov 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TRIAL BOX STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039423 ↗
• MalfunctionJun 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SIGMA SIZE 4 LEFT FEMUR TRIAL AND SIZE 4 BOX TRIAL ARE STUCK TOGETHER AND THE BOX TRIAL SCREW IS STRIPPED. THE BOX TRIAL CANNOT BE REMOVED FROM THE FEMUR TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7586338 ↗
• MalfunctionFeb 28, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT SIGMA LT FEMUR TRIAL IS NOT CONNECTING PROPERLY TO THE BOX TRIALS AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302683 ↗