P.F.C. SIGMA 96-1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295234579), received between Sep 8, 2017 and Apr 5, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TRIAL WAS WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682014 ↗
• MalfunctionJan 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOX TRIAL SET SCREW IS STRIPPED, AND STUCK IN FEMUR TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186350 ↗
• 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 15796817 ↗
• MalfunctionJul 13, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE FEMORAL TRIAL LUG HOLE HAS METAL SHARD CREATING PLASTIC INSERT DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158769 ↗
• MalfunctionJul 7, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  THE RECESS TO ATTACH THE TC3 BOX IS WORN SO IT NO LONGER LOCKS IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129910 ↗
• MalfunctionMay 23, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SIGMA SIZE 3 LEFT PC FEMUR BOX IS CROSS THREADED AND STRIPPED INSIDE THE FEMUR AND WILL NOT COME APART. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637557 ↗
• 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 8463769 ↗
• MalfunctionMar 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  HAD DIFFICULTLY MATING THE BOX TRIAL TO FEMORAL TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416241 ↗
• MalfunctionFeb 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SIZE 3 SIGMA BOX WOULD NOT UNSCREW FROM THE FEMORAL TRIAL. THE SCREW SEEMS TO BE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8300948 ↗
• MalfunctionSep 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE FEMORAL TRIAL HAS STABILIZED BOX TRIAL ATTACHED AND WAS UNABLE TO DISASSEMBLE APPEARS SCREW HAS BEEN STRIPPED.

  Patient problems: No Information

  MAUDE report 6852891 ↗