SIGMA AOX 1961-92-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295076148), received between Jan 11, 2019 and Jun 3, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED SWAPPING THE INSERT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19449713 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES DATED (B)(6) 2020, INDICATED THAT THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES DATED (B)(6) 2020, INDICATED THAT THE PATIENT HAS HAD DIFFICULTIES WITH BLEEDING FROM THE PROXIMAL ASPECT OF HER WOUND. THE PATIENT'S DRESSING WAS REMOVED AND HAS BLOODY SEROUS DRAINAGE FROM THE VERY PROXIMAL ASPECT OF HER INCISION. THERE WAS SLOW WOUND HEALING. PATIENT WAS MINIMALLY TENDER TO PALPATION, AND THE REMAINDER OF THE INCISION LOOKED EXCELLENT. PATIENT HAD EXPECTED POSTOPERATIVE ECCHYMOSIS WITH MINIMAL SWELLING. TREATMENT INCLUDED PRESSURE DRESSING WITH ABDS AND AN ACE WRAP, AS WELL AS A KNEE IMMOBILIZER. OFFICE NOTES DATED (B)(6) 2020, INDICATED THAT THE PATIENT WAS STATUS POST RIGHT KNEE REPLACEMENT THREE WEEKS AGO. THE PATIENT DID WELL WITH THE KNEE INITIALLY BUT HAD A GALLBLADDER ATTACK, AND HAD A SURGERY TO REMOVE THE GALLBLADDER. DUE TO THIS, THE PATIENT WAS PUT ON HEPARIN WHICH CAUSED A POSTOP HEMARTHROSIS OF THE RIGHT TOTAL KNEE. SINCE THEN, THE VERY PROXIMAL PORTION OF THE INCISION HAD SOME SMALL BREAKDOWN AND DEHISCENCE. TREATMENT I

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Swelling/ Edema; Wound Dehiscence

  MAUDE report 10928401 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY AND TIBIAL IMPLANT MIGRATION/LOOSENING. DATE OF IMPLANTATION: (B)(6) 2013, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL CONSTRUCT AND INSERT.

  Patient problems: Joint Laxity

  MAUDE report 10928319 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8239984 ↗