SIGMA AOX 1961-92-131Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295076513), received between Jul 21, 2020 and May 5, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN. DOI: (B)(6), 2017 DOR: (B)6), 2026 AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 25084196 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSERT WAS EXCHANGED DUE TO PAIN AND STIFFNESS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23882327 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. WAS/WERE, THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT, BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: Unspecified Infection

  MAUDE report 19467802 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MILD PAIN ASSOCIATED WITH INSTABILITY. POLY EXCHANGE PERFORMED SUCCESSFULLY. COMPONENTS APPEARED WELL ALIGNED, NOT UNDERSIZED, NOT OVER RESECTED, MAL ROTATED OR PUT IN WITH PATIENT SPECIFIC TECHNIQUE. NO WEAR WAS EVIDENT TO CONTRIBUTE TO INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11711945 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LATE LIGAMENTOUS INSTABILITY. NO DELAY IN SURGERY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11351000 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2014; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11126245 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE INSTABILITY WAS NOT DUE TO POLY WEAR.

  Patient problems: No Code Available

  MAUDE report 10484895 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE SURGEON ELECTED TO CHANGE THE FEMUR TO A TC3 FEMUR AND POLY. DOI: (B)(6) 2014; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10307874 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THE POLY WAS UPSIZED FROM A 10 MM TO A 15 MM AND ACHIEVED PROPER STABILITY. THE ONLY PRODUCT CHANGED OUT WAS THE POLY INSERT. DOI: (B)(6) 2016 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10305168 ↗