P.F.C. SIGMA 96-1351Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295237242), received between Sep 20, 2017 and Jul 18, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT THE TIBIAL INSERT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15043651 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT CURVED TIBIAL TRIAL WAS BROKEN BY SURGEON WHEN EXTRACTING AFTER TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927834 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THE SIGMA SZ 2.5 8 MM FB CVD INSERT TRIALS HAVE BROKEN. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703715 ↗
• MalfunctionDec 4, 2018Break; Naturally Worn; Break; Naturally Worn

  TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE.

  Patient problems: No Code Available

  MAUDE report 8128796 ↗
• MalfunctionSep 20, 2017Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL BROKE DURING TRIAL REDUCTION.

  Patient problems: No Information

  MAUDE report 6878695 ↗