SIGMA AOX 1961-92-133Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295076537), received between Mar 6, 2018 and Jan 10, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 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. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21126678 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FLEXION INSTABILITY. THE SURGEON UPSIZED THE POLY AND WENT TO A TC3 INSERT. THE SURGEON ALSO RESURFACED THE PATELLA. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12014194 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS INFECTED. ALL REVISION COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10143558 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION THAT TRACKED ALL THE WAY TO THE JOINT. THE SURGEON PERFORMED AN I&D AND EXCHANGED THE 3 X 15MM RP INSERT WITH SAME SIZE. DOI: (B)(6) 2020. DOI: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9832253 ↗
• InjuryJan 14, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9586945 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED KNEE : INFECTION - DEEP. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Code Available; Osteolysis; Unspecified Infection

  MAUDE report 9558382 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNSTABLE KNEE. THEY HAD TO PUT IN A HINGE KNEE. DOI: (B)(6) 2017; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9125115 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT ALSO UNDERWENT A POLY EXCHANGE FOR THE SAME REASON AT THIS HOSPITAL ON (B)(6) 2019 AND WAS CAPTURED IN (B)(4). DOI: (B)(6) 2019; (B)(6) 2019 (INSERT); DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9078126 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8653880 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE PATIENT FELL AND OPENED INCISION. A POLY REPLACEMENT WAS DONE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8582182 ↗
• InjuryMar 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PER THE SURGEON THE PATIENT HAD KNEE PAIN. PATIENT HAD AN UNSURFACED PATELLA FROM INITIAL SURGERY. SURGERY RESURFACED THE PATELLA. ALSO, PATIENT WAS A LITTLE UNSTABLE WITH CURRENT 15 MM INSERT, AND THE SURGEON WENT TO A 17.5 MM INSERT. NO INSTRUMENTATION BROKE DURING CASE. UNKNOWN ON ORIGINAL CASE SO DON¿T HAVE THE PRODUCT NUMBERS FOR FEMUR AND TIBIA THAT STAYED IN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 7316001 ↗