SIGMA AOX 1961-92-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295076681), received between Sep 8, 2023 and Sep 25, 2023 — 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.

• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MULTIPLE INFECTIONS SINCE THE ORIGINAL TKA WAS DONE. EXPLANTED AND A CEMENT SPACER WAS PUT IN. NO SURGICAL DELAY. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17807594 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SUSPECTED FAILED SUPPRESSION; DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANT: (B)(6) 2013. DATE OF REVISION #1: (B)(6) 2018. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT:(B)(6) 2023. (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 17711418 ↗