SIGMA AOX 1961-92-141Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295076582), received between Sep 6, 2019 and Jan 2, 2026 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS A LOOSENING OF INSERT AT UNKNOWN INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23943173 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 21027120 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH PAIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 17190390 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT¿S KNEE WAS REVISED DUE TO PAIN, PER SURGEON DISCRETION. TIBIA WAS SUSPECTED TO SHOW SOME SIGNS OF LOOSENING BUT NOTHING CONCRETE. DOI: UNKNOWN, DOR: UNKNOWN, UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15163752 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT KNEE WAS REVISED DUE TO SIGNIFICANT FLEXION CONTRACTURE. THE FEMORAL COMPONENT ONLY WAS REVISED TO RAISE THE JOINT LINE. TIBIAL COMPONENTS WERE LEFT IN SITU. DOI: (B)(6) 2018; DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 12915849 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11329885 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF THE RIGHT TOTAL KNEE TO ADDRESS INFECTION DATE OF IMPLANTATION: (B)(6) 2017, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: EXPLANTATION OF ALL IMPLANTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11251463 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10488235 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A DEVELOPED LAXITY. A THICK INSERT WAS PLACED. NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10466051 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED ALL COMPONENTS AND PUT IN SPACERS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10271847 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS PER SURGEON, THE PATIENT FELT HE HAD LAXITY IN KNEE AND POSSIBLY MID FLEXION INSTABILITY. SURGEON RETAINED ALL COMPONENTS EXCEPT INSERT. THE SURGEON DID POLY EXCHANGE AND UPSIZED THE POLY. DOI: (B)(6) 2018. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9911637 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK SYNDROME. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9565773 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GROSS INSTABILITY. THE FEMUR WAS REVISED TO A HIGHER CONSTRAINT. DOI: (B)(6) 2017, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8972021 ↗