SIGMA AOX 1961-92-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295076452), received between Jul 31, 2020 and Aug 18, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 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. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22829825 ↗
• InjurySep 27, 2024Adverse 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 PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE

  Patient problems: Pain

  MAUDE report 20323053 ↗
• InjuryMar 31, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY KNEE WAS REVISED IN 2008, A TC3 FEMOR WAS USED AND A PRIMARY PS RP INSERT WAS USED. THE POST WAS WORN SEVERELY ON THE INSERT AND THE KNEE WAS UNSTABLE. NO SURGICAL DELAY. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16655047 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15092607 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTION SO THE DOCTOR IS SWITCHING OUT THE POLYETHYLENE 12.5 SIGMA RP INSERT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2010, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14786974 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN , DOR: (B)(6) 2021 , LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12836565 ↗
• InjuryJan 7, 2021Adverse 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) 2020 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11131540 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10351658 ↗