P.F.C. SIGMA 96-1242Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295236276), received between Nov 23, 2021 and Jan 26, 2023 — classified as 4 malfunctions.

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

• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT THE UPROD SCREW ON ANKLE CLAMP IS CROSS-THREADED. ANKLE CLAMP MEDIALIZER ALSO WON¿T MOVE. BOTH LINER TRIALS ALSO CHIPPED UPON REMOVAL. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246232 ↗
• MalfunctionMay 7, 2022Break; Crack; Naturally Worn; Break; Crack; Naturally Worn

  IT WAS REPORTED THAT SIGMA TRIAL INSERT BROKE DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317288 ↗
• MalfunctionNov 23, 2021Break; Naturally Worn; Break; Naturally Worn

  THE HOSPITAL IS REPORTING THAT THE PLASTIC IS STARTING TO BREAK AWAY FROM THE TRAILS DUE TO WEAR AND TEAR. NO REPORTED SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860309 ↗
• MalfunctionNov 23, 2021Break; Naturally Worn; Break; Naturally Worn

  THE HOSPITAL IS REPORTING THAT THE PLASTIC IS TRARTING TO BREAK AWAY FROM THE TRAILS DUE TO WEAR AND TEAR. NO REPORTED SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860235 ↗