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P.F.C. SIGMA 96-2147Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED 4 (STAB) 25mm GVF · Class 3 · Implant

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

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295241379), received between May 19, 2021 and May 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

  • Device Dislodged or Dislocated1

Patient problems

  • Joint Dislocation1
  • Joint Laxity1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PATIENT WITH NO PATELLA BECAME UNSTABLE AND DISLOCATED HER SIGMA C/S R/P STABILIZED INSERT. SHE WAS REVISED TO AN S-ROM HINGE FEMORAL COMPONENT AND HINGED INSERT. LEFT KNEE.

    Patient problems: Joint Dislocation; Joint Laxity

    MAUDE report 11853229 ↗

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Sources and updates

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