SIGMA AOX 1961-92-024Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295076155), received between Dec 13, 2022 and Feb 4, 2023 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 16301911 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE BECAME INSTABILITY AND NEEDED TO BE REVISED TO A HINGE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15973990 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2020; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15966194 ↗