SIGMA AOX 1961-92-157Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295076711), received between Jan 12, 2021 and Jan 15, 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 18, 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.

• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WAS RECEIVED AND REVIEWED: PRIMARY OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO POLYETHYLENE INSERT WEAR WITH INSERT SPINOUT MEDIAL PATELLAR TILT AND FLEXION INSTABILITY. UPON ENTERING THE JOINT, MILD SYNOVITIS WAS ENCOUNTERED. THE FEMORAL COMPONENT AND INSERT WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO EXTENSOR MECHANISM RUPTURE, SIGNIFICANT MEDIAL TILT OF THE PATELLA AND FLEXION INSTABILITY. UPON ENTERING THE JOINT, MILD SYNOVITIS AND FLEXION CONTRACTURE WAS ENCOUNTERED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION OF THE TIBIAL INSERT DUE TO ACUTE SEPSIS, DEEP JOINT POST-OPERATIVE INFECTION. UPON ENTERING THE JOINT, GROSS PUSS WAS ENCOUNTERED, RE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11176129 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AFTER HAVING A PATELLA TENDON/POLY EXCHANGE ON THE (B)(6). I&D, POLY EXCHANGE WAS PERFORMED AND SAME SIZE POLY WAS INSERTED. THIS IS ALL THE INFORMATION THAT CURRENTLY HAVE FOR THIS CASE. DOI: (B)(6) 2020 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11155444 ↗