SIGMA AOX 1961-92-126Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295076490), received between Sep 3, 2020 and Oct 30, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT HAD A LEFT CEMENTED TOTAL KNEE ARTHROPLASTY DUE TO RHEUMATOID ARTHRITIS, SEVERE MEDIAL TIBIAL BONE LOSS AND VARUS DEFORMITY SEVERE OSTEOPOROSIS, AND INSTABILITY. DURING THE PROCEDURE, THE SURGEON REPORTED FINDING SEVERE VARUS DISEASE AND MEDIAL TIBIAL BONE LOSS, SEVERE OSTEOPOROSIS WITH COMPROMISE OF THE ANTERIOR FEMORAL CORTEX AND SEVERE SYNOVITIS. DEPUY COMPONENTS AND CEMENT WERE UTILIZED. ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS RECURRENT/CHRONIC INFECTION MRSA. THE TIBIAL COMPONENT INSERT WAS REVISED. IT IS NOTED THAT PATIENT IS STATUS POST TWO I&D WITH WASHOUT. GROSS PUS WAS FOUND WITHIN THE KNEE ALONG WITH SYNOVITIS. ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL KNEE, TIBIAL COMPONENTS TO ADDRESS CHRONIC INFECTION WITH A LARGE FLUID COLLECTION INFERIOR TO THE JOINT. THE SURGEON WAS HESITANT TO EXPLANT BECAUSE THE PATIENT HAD A LONG CEMENTED STEM AND VERY POOR BONE QUALITY. DURING THE PROCEDURE, THE SURGEON OBSERVED BLOODY SEROSANGUINEOUS FLUID, SYNOVITIS AND THE TISSUE AROUND TIBIAL ¿NEVER HEALED¿.

  Patient problems: Impaired Healing; No Code Available; Synovitis; Unspecified Infection

  MAUDE report 10764068 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT TO ADDRESS RHEUMATOID ARTHRITIS, WITH SEVERE MEDIAL TIBIAL BONE LOSS, VARUS DEFORMITY, AND INSTABILITY, AS WELL AS OSTEOPOROSIS. THE KNEE WAS REPORTEDLY COMPLEX FOR A PRIMARY, REQUIRING ESSENTIALLY REVISION STEMMED COMPONENTS FOR BOTH THE FEMORAL AND TIBIAL CONSTRUCTS. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2020, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS RECURRENT/CHRONIC INFECTION, WITH METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS. THIS PROCEDURE WAS ACTUALLY THE THIRD WASHOUT, TWO OTHERS THAT PRECEDED IT WERE CARRIED OUT BY TWO SEPARATE PHYSICIANS AT TWO DIFFERENT INSTITUTIONS (AND DID NOT INVOLVE REVISION OF COMPONENTS. THE SURGEON IN THIS PROCEDURE IDENTIFIED MULTIPLE POCKETS OF PUS, WHICH WERE AGGRESSIVELY DEBRIDED, INCLUDING A SUBSTANTIAL ONE BENEATH THE QUADRICEPS MUSCLE. THE TIBIAL INSERT WAS REVISED DURING THIS REVISION. ON (B)(6) 2020, PATIENT PRESENTED IN CLINICAL VISIT WITH LEFT KNEE ANTEROMEDIAL BLOODY EFFUSION. KNEE HAS BEEN ASPIRATED AT ANOTHER FACILITY, WITH ONLY 375 NEUTROPHILS--DOES NOT APPEAR TO BE INFECTED. THE WOUND IS DRAINING THOUGH, AND NEEDS TO BE DEBRIDED SURGICALLY. THE

  Patient problems: Edema; Fluid Discharge; No Code Available; Unspecified Infection

  MAUDE report 10691252 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS A LEFT TOTAL KNEE THAT HAS POOR RANGE OF MOTION. THE SURGEON REMOVED THE TIBIAL INSERT AND IMPLANTED A THINNER SIZE. THE COMPONENTS ARE WELL FIXED AND RETAINED. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10488054 ↗