SIGMA AOX 1961-92-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295076100), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT FELL AFTER SUCCESSFUL TKA. HER 2 X 15 SIGMA RP CR POLY SPUN OUT. CLOSED REDUCTION WAS ATTEMPTED WITHOUT SUCCESS. THE SURGEON REVISED THE POLY TO A 2 X 17.5 RP CR. DURING THIS PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT MCL TRAUMA. THE MCL WAS REPAIRED. THERE IS NO FURTHER INFO/XRAYS AVAIL AT THIS TIME. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Weakness

  MAUDE report 9310454 ↗