SIGMA AOX 1961-92-155Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295076698), received between Feb 19, 2021 and Jul 30, 2026 — 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.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that SIG RP AOX STB INS SZ5 20 was associated with an infected total knee. The insert had been implanted and was later removed during a revision procedure in which the poly was removed and irrigation and debridement were performed. Reported patient impact included a painful, swollen, infected knee, with infection, pain, edema, and device revision or replacement. Affected side: Right.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50081747 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2016, DATE OF REVISION: (B)(6) 2017, (LEFT KNEE). TREATMENT: I&D, REVISION OF INSERT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Ischemia; Necrosis; Unspecified Tissue Injury

  MAUDE report 11350901 ↗