P.F.C. SIGMA 96-1054Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295234791), received between Jun 5, 2019 and May 23, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 4 SCREW OF THE TC3 BOX IS COMPLETELY GROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469014 ↗
• MalfunctionOct 5, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SCREW FOR THE SIZE 4 TC3 TRIAL BOX FEMORAL COMPONENT IS CROSS THREADED AND NEEDS TO BE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12575899 ↗
• MalfunctionAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE THEY WERE USING THE HEXAGONAL SCREW DRIVER TO TIGHTEN THE SCREW, IT BECAME STRIPPED. THEY TRIED TO UNSCREW IT MULTIPLE TIMES WITHOUT ANY LUCK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940432 ↗
• MalfunctionJun 5, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW OF THE SIZE 3 AND 4 TC3 BOX TRIAL WAS STRIPPED. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672054 ↗