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P.F.C. SIGMA 96-1350Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA CURVED TIBIAL INSERT TRIAL SZ 3 8mm 71mm M/L 47mm A/P · Class 1

All models of P.F.C. SIGMA (487)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295237228), received between May 2, 2018 and Oct 21, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

Device problems

  • Break6
  • Device-Device Incompatibility1
  • Naturally Worn1
  • Scratched Material1

Patient problems

  • No Consequences Or Impact To Patient4
  • No Clinical Signs, Symptoms or Conditions2
  • No Code Available1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 21, 2021Break; Break

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT ONE SMALL SINGLE FRAGMENT CHIPPED OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12674560 ↗
  • MalfunctionOct 4, 2021Break; Break

    IT WAS REPORTED THAT AFTER DOING AN INTRA OPERATIVE TRIAL THE SURGICAL ASSISTANT WAS REMOVING THE BEARING TRIAL WITH A RETRACTOR AND THE BACK EDGE OF THE PERIPHERAL LOCKING TAB BROKE OFF. THIS WAS EASILY REMOVED FROM THE KNEE WITH NO PATIENT IMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12569528 ↗
  • MalfunctionOct 22, 2020Break; Break

    IT WAS REPORTED THAT THE PFCSIG INS TRL CURVD LOCKING TABS WERE BROKEN OFF. THE SP2 TIBIAL RADEL IMPACTOR WAS CHIPPED. ALL PIECES WERE RETRIEVED AND ACCOUNTED FOR. THERE WAS NO SURGICAL DELAY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10717987 ↗
  • MalfunctionFeb 18, 2020Break; Scratched Material; Break; Scratched Material

    IT WAS REPORTED ON (B)(6) 2019 A SIZE 3 8MM FB SIGMA POLY TRIAL WAS BEING USED IN A CASE AND WAS DAMAGED AROUND THE BOTTOM WHEN THE LOCKING MECHANISM IS. FOLLOW-UP WITH THE SALES REPRESENTATIVE DETERMINED THAT IT WAS BROKEN ON THE BASE. THE BROKEN PART WAS THROWN AWAY. IT WAS BROKEN INTO TWO PARTS. NO PARTS REMAINED IN THE PATIENT. NO SURGICAL DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9720219 ↗
  • MalfunctionFeb 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

    THE TRIAL LINER(#961350) DOES NOT CLIP WELL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9689238 ↗
  • MalfunctionDec 4, 2018Break; Naturally Worn; Break; Naturally Worn

    TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE.

    Patient problems: No Code Available

    MAUDE report 8128775 ↗
  • MalfunctionMay 2, 2018Break; Break

    IT WAS REPORTED THAT THE PLASTIC WAS BROKEN. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7479189 ↗

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Sources and updates

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