SIGMA AOX 1961-92-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295076551), received between Nov 11, 2017 and Aug 14, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 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) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 17539966 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TORN MCL AND PCL AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: THICKER IMPLANT REQUIRED WITH AUGMENTATION.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17224178 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9009755 ↗
• InjuryJul 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. I AND D POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2018, DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7670267 ↗
• InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE KNEE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 7099062 ↗
• InjuryNov 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT BECAME INFECTED AFTER PT PULLED THE SCAB OFF THE PATIENT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7023382 ↗