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SIGMA AOX 1961-92-144Recalls & reported problems

Depuy Orthopaedics, Inc. · SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 17.5mm · Class 3 · Implant

All models of SIGMA AOX (53)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295076612), received between Sep 8, 2017 and Jul 14, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Adverse Event Without Identified Device or Use Problem3
  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection3
  • Joint Laxity1
  • No Code Available1
  • Pain1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY IN KNEE. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

    Patient problems: Joint Laxity; Pain

    MAUDE report 17324911 ↗
  • InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR DEEP, CHRONIC INFECTION, POSITIVE CULTURE FOR STAPHYLOCOCCUS CAPRAE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2017. DOE: (B)(6) 2019. (LEFT KNEE).

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 9483942 ↗
  • InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED TO ADDRESS STAPH INFECTION. THE SURGEON PERFORMED AN INSERT AND WASH OUT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 7767275 ↗
  • InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS REVISED TO ADDRESS INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 6852588 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices

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Sources and updates

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