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P.F.C. SIGMA 1581-26-117Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED 6 17.5mm XLK · Class 2 · 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 10603295064855), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Loss of Range of Motion1

Recent adverse event reports

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

  • InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD PRIOR TOTAL KNEE. THE PATIENT WAS BROUGHT BACK TO CHANGE THE POLY TO GIVE THE PATIENT MORE RANGE OF MOTION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

    Patient problems: Loss of Range of Motion

    MAUDE report 13889180 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

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Sources and updates

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