SIGMA AOX 1961-92-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295076445), received between Nov 5, 2020 and Oct 4, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO EXCESSIVE POLY WEAR. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20370315 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT TOTAL KNEE DONE ON (B)(6)2016. PATIENT FELL RECENTLY. EXHIBITED KNEE PAIN. X-RAYS SHOWED POSSIBLE LOOSE TIBIA. CEMENTED TIBIA WAS LOOSE. THERE WAS NO CEMENT ADHERING TO THE TIBIAL PLATE. CEMENT WAS STUCK ON THE TIBIAL PLATEAU AND IN THE CANAL. WAS THE LOOSENING OF THE IMPLANT CAUSED BY THE FALL OR ORIGINAL CEMENT USED. WE WERE UNABLE TO DETERMINE WHAT TYPE OF CEMENT WAS USED. THE HOSPITAL LOGS DO NOT GO BACK THAT FAR TO VERIFY IT.

  Patient problems: Fall; Pain

  MAUDE report 19305747 ↗
• InjuryMay 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD A RIGHT TOTAL KNEE DONE ON (B)(6) 2016. PATIENT FELL RECENTLY. EXHIBITED KNEE PAIN. X-RAYS SHOWED POSSIBLE LOOSE TIBIA. CEMENTED TIBIA WAS LOOSE. THERE WAS NO CEMENT ADHERING TO THE TIBIAL PLATE. CEMENT WAS STUCK ON THE TIBIAL PLATEAU AND IN THE CANAL. WAS THE LOOSENING OF THE IMPLANT CAUSED BY THE FALL OR ORIGINAL CEMENT USED. WE WERE UNABLE TO DETERMINE WHAT TYPE OF CEMENT WAS USED. THE HOSPITAL LOGS DO NOT GO BACK THAT FAR TO VERIFY IT.

  Patient problems: Fall; Pain

  MAUDE report 19305628 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY OF THE FEMORAL COMPONENT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19281102 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO LOOSE TIBIAL IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 15845745 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14434031 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ORIGINAL IMPLANT DATE IS UNKNOWN. NO SURGICAL DELAY REPORTED. THERE WAS NO LOOSENING OF COMPONENTS DURING THIS CASE. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10791792 ↗