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SIGMA 96-2316Recalls & reported problems

Depuy (Ireland) · SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE 1.5 22.5mm GVF · Class 3 · Implant

Data updated Oct 13, 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 10603295242017), received between Jun 1, 2021 and Jun 1, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Joint Laxity1

Recent adverse event reports

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

  • InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 11914401 ↗

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Sources and updates

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