P.F.C. SIGMA 96-1260Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295236481), received between Nov 23, 2021 and Apr 29, 2022 — 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.

• MalfunctionApr 29, 2022Break; Crack; Naturally Worn; Break; Crack; Naturally Worn

  INSTRUMENTS ARE BROKEN DUE TO WEAR AND TEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250246 ↗
• MalfunctionApr 21, 2022Break; Break

  IT WAS REPORTED THAT THE BOTTOM OF THE 5/8PLI SIGMA INSERT BROKE OFF THAT ENGAGES IN THE TIBIA BASE PLATE. IT BROKE DUE TO OVERUSE. ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171541 ↗
• MalfunctionMar 10, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES. THE TIBIAL IMPACTOR BROKE INTO TWO PIECES AND ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724814 ↗
• 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 12860292 ↗