SIGMA AOX 1961-92-145Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295076629), received between May 24, 2018 and Jul 26, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO PAIN. AT REVISION THE ARTICULAR SURFACE OF THE FIXED-BEARING POLYETHYLENE TIBIAL INSERT SHOWS IMPINGEMENT OF THE INTERCONDYLAR EMINENCE. DOI: ON (B)(6) 2022. DOE: ON (B)(6) 2024.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 19843108 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO AN INFECTION. DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: (B)(6) 2023, TREATMENT: INSERT AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17597608 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME IN NOT FEELING WELL AND HAD PAIN IN HIS KNEE. AFTER EXAMINING, IT WAS DETERMINED THAT HIS KNEE WAS SEPTIC. THE SURGEON OPENED THE KNEE, WASHED IT OUT AND SWAPPED THE POLY AND PATELLA BUTTON. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2014, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17571478 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED KNEE PAIN AND DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT:(B)(6) 2017. DATE OF EVENT: UNK 2019. (LEFT KNEE). TREATMENT: EXPLANT OF ALL COMPONENTS, EIGHT WEEKS OF ANTIBIOTICS (RE-IMPLANTATION OF COMPONENTS PLANNED AFTER ANTIBIOTIC TREATMENT).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16918898 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FAILING SUPPRESSION AND DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION #1: (B)(6) 2020. DATE OF REVISION #2: UNK. DATE OF EVENT: (B)(6) 2023. LEFT KNEE. TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Erythema; Inflammation; Joint Laxity; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16195254 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION AND I&D DUE TO INFECTION. INSERT WAS REMOVED. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. RIGHT KNEE. TREATMENT: REMOVAL OF INSERT AND I&D.

  Patient problems: Cellulitis; Synovitis; Unspecified Infection

  MAUDE report 14594918 ↗
• InjuryMay 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY WITH PAIN SECONDARY TO THE INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. TREATMENT INCLUDES REVISION OF THE INSERT. DOI: (B)(6) 2015; DOE: (B)(6) 2018; DOR: (B)(6) 2018; (LEFT KNEE).

  Patient problems: Not Applicable; Pain

  MAUDE report 7540383 ↗