SIGMA AOX 1961-92-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295076292), received between Sep 15, 2017 and Jun 28, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS . CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19632751 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2024. DATE OF EVENT: 02 APR 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19164068 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GLOBAL INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9311288 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT KNEE REVISION TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019 (RIGHT KNEE). INSERT REVISED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; No Code Available; Pain; Synovitis; Unspecified Infection

  MAUDE report 8700075 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. PATIENT HAD RTK ON (B)(6) 2019, RETURNED AND WAS OPERATED ON THIS DAY BECAUSE OF INFECTION WITH AN UNKNOWN BUG, POLY EXCHANGE AND I AND D WAS PERFORMED. THE SAME SIZE POLY WAS UTILIZED. RETAINED IMPLANTS WERE AS SUCH, 960016/632489, 129433160/8080026, 960103/9074215. NEW POLY 196192062/8894615. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8686335 ↗
• InjurySep 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATES AE RECEIVED FOR INFECTION-DEEP. EVENT MEETS THE DEFINITION OF SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. TREATMENT INCLUDES IRRIGATION AND DEBRIDEMENT. EVENT IS CONSIDERED RESOLVED AS OF (B)(6) 2017. UPDATE AUG 23, 2017 REVISION DUE TO INFECTION. DEPUY INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 6868488 ↗