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P.F.C. SIGMA 96-1460Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 5 8mm 83mm M/L 55mm 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
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295238812), received between Jul 5, 2018 and Jan 18, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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

  • Break8
  • Device Damaged Prior to Use1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 18, 2023Break; Break

    SPD NOTICED WHEN REWRAPPING THE SET THAT THIS TRIAL HAS A PIECE BROKEN OFF. THE BROKEN PIECE WAS BROKEN AND THE PAN AS WELL AND DISCARDED. NO ADVERSE AFFECTS ON THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16196426 ↗
  • MalfunctionNov 20, 2022Break; Break

    INSTRUMENT BROKE DURING KNEE SURGERY TODAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15831560 ↗
  • MalfunctionJan 31, 2022Break; Break

    IT WAS REPORTED THAT THE PERIPHERAL FIXATION ON POLY TRIAL BROKE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13392391 ↗
  • MalfunctionDec 16, 2021Break; Break

    IT WAS REPORTED THAT THE HOSPITAL HAS REPORTED 2 INSERT TRIALS AS BEING CHIPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13020290 ↗
  • MalfunctionNov 4, 2021Break; Break

    IT WAS REPORTED THAT THE IMPLANT BROKE DURING SURGERY YESTERDAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12750767 ↗
  • MalfunctionJul 21, 2021Break; Break

    IT WAS REPORTED THAT THE INSTRUMENT BROKEN IN STERILIZATION. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12205958 ↗
  • MalfunctionJun 15, 2021Break; Break

    IT WAS REPORTED THAT THE PLASTIC TIP ON POLY TRIAL BROKE OFF. IT WAS REMOVED FROM THE PATIENT. THIS DID NOT EXTEND THE SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12000579 ↗
  • MalfunctionJun 7, 2021Break; Break

    STAFF REPORTED INSTRUMENT HAD BROKEN DURING KNEE SURGERY. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11946734 ↗
  • MalfunctionJul 5, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

    IT WAS REPORTED THAT THE SIZE 5, 8MM SIGMA FB PS INSERT TRIAL IS DAMAGED AND SPD REFUSES TO PROCESS THE ITEM. ITEM NEEDS TO BE REPLACED. NO SURGICAL DELAY. SCRATCHING AND GOUGING WERE EVIDENT ON THE TRIAL INSTRUMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7663663 ↗

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Sources and updates

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