SIGMA AOX 1961-92-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295076520), received between Apr 16, 2019 and Apr 8, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POLY EXCHANGE FOR PAIN. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24816037 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085075 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085074 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE NO ADVERSE EFFECTS.

  Patient problems: Joint Laxity

  MAUDE report 24079853 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI- (B)(6) 2020. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23853705 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22350593 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE DONE ON (B)(6) 2024. IT RECENTLY SHOWED SIGNS OF INFECTION. SO THE DOCTOR DID A WASHOUT AND POLY EXCHANGE ON (B)(6) 2024. NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19732672 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14517764 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS TRAUMATIC FALL AND TORE HER MCL AND OPENED HER ARTHROPLASTY. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Wound Dehiscence

  MAUDE report 12632680 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BRUISED HIS LEFT KNEE ON OR ABOUT (B)(6) 2020. CT AND XRAY IMAGING WERE USED TO RULE OUT FRACTURE OF THE LEFT KNEE. PATIENT WAS STILL COMPLAINING OF PAIN AND FLUID WAS TAPPED FROM THE KNEE AND SENT FOR CULTURE. THE CULTURE RETURNED POSITIVE FOR STAPH INFECTION. I&D WITH POLY EXCHANGE WERE PERFORMED. ALL COMPONENTS WERE FOUND TO BE WELL FIXED. DOI: (B)(6) 2013, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Bruise/Contusion; No Code Available; Pain; Unspecified Infection

  MAUDE report 10301778 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I & D CLEAN OUT AND REPLACED POLY WERE PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10106435 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD DATED (B)(6) 2020, IT WAS REPORTED THAT PATIENT SUFFERED FROM ADHESION, PAIN, ALLERGIC REACTION. DOI: (B)(6) 2018, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9908051 ↗
• InjuryApr 16, 2019Break; Fracture; Break; Fracture

  PATIENT'S NIECE WAS CONTACTED. THERE WAS A REVISION DUE TO SWELLING, PAIN, INFECTION, BURNING, IMPLANT FALLING PART (INSERT). CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2015; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Burning Sensation; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8518472 ↗