SIGMA AOX 1961-92-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295076421), received between Apr 21, 2021 and Jun 25, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PATELLAR GRINDING, CLUNK : PATELLA CLUNK SYNDROME. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. ADDITIONAL INFORMATION INDICATED THE PATIENT UNDERWENT A CLOSED REDUCTION/MANIPULATION TO ADDRESS INDICATED ISSUES AS WELL AS SYNOVECTOMY, AND HYPERTROPHIC SCAR REMOVAL ON (B)(6) 2021. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION #1: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6). 2021 (LEFT KNEE).

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 12068041 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO LOOSENING REPORTED. NO DELAY TO SURGERY. DOI: (B)(6) 2014. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11699628 ↗