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SIGMA AOX 1961-92-123Recalls & reported problems

Depuy Orthopaedics, Inc. · SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 15mm · Class 3 · Implant

All models of SIGMA AOX (53)

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 10603295076469), received between Feb 8, 2022 and Feb 8, 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

  • Joint Laxity1

Recent adverse event reports

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

  • InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED DUE TO SOFT TISSUE LAXITY. POLY SWAP WAS DONE AND POLY WAS INCREASED IN THICKNESS FROM 15MM TO 20MM. ALL COMPONENTS WERE WELL FIXED. DATE AND LOCATION OF PRIMARY SURGERY ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 13478973 ↗

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Sources and updates

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