SIGMA RPF AOX 1961-91-053Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295075998), received between May 10, 2019 and May 10, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryMay 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE SIGMA RPF FEMUR AND INSERT REMOVED DUE TO BEING OVERSIZED AND POSSIBLY LOOSE. THE FEMUR WAS LOOSE WITH NO CONTACT OF AN IMPLANT TO ANTERIOR AND POSTERIOR FACES. THE COMPONENT WAS TOO LARGE FOR THE PATIENT. NO INFECTION PRESENT. RE-IMPLANTED TO TC3 WITH CEMENTED STEM AND TC3 INSERT. MBT REVISION TRAY FROM ORIGINAL SURGERY WAS RETAINED. DOI: (B)(6) 2016; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8601551 ↗