P.F.C. SIGMA 96-2034Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295240778), received between Mar 18, 2020 and Jun 9, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO CONTINUED INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10134334 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, DISTAL FEMUR FRACTURE, FLEXION INSTABILITY AND TIBIAL LOOSENING AT THE BONE TO CEMENT INTERFACE DUE TO FALL. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT HAD A PRIOR RIGHT KNEE REVISION DONE SOMETIME WITHIN THE LAST 10 YEARS IN (B)(6) FOR TIBIAL LOOSENING. THE SURGEON TOLD THE SALES REP THAT FROM LOOKING AT THE X-RAY HIS PLAN WAS TO NAIL THE FEMUR THRU THE SIGMA CR FEMUR. HE ALSO SAID THAT HE BELIEVES THE TIBIAL COMPONENT ALSO BECAME LOOSE AFTER THE FALL, SO HE WANTED TO REVISION THE TIBIA. HE SAID THE PATIENT NEVER COMPLAINED OF PAIN OR INSTABILITY BEFORE THE FALL, EVEN THOUGH UNDER HIS EXAM, THE PATIENT HAD A LOT OF FLEXION INSTABILITY. HE FELT LIKE HE NEEDED TO ADD THICKNESS TO THE ALREADY THICK TRAY THE PATIENT CURRENTLY HAD IN. THE SURGEON IN (B)(6), DIDN'T USE A STEM WITH HIS REVISION TIBIA. THE SURGEON NAILED THE FEMUR, THEN REMOVED THE LOOSE TIBIAL COMPONENT WITH EASE. HE ENDED UP USING THE NEXT SIZE TIBIAL SLEEVE (37MM), PUTTING IN A 115 X 14 PRESSFIT STEM, AND WENT WITH THE 25MM THICK TRAY AND A 10MM INSERT. HE WAS HAPPY WITH THE STABILITY AND WITH HOW THE FRACTURE WAS NAILED. DOI: LAST 10 YEARS. DOR: (B)(6

  Patient problems: No Code Available; Pain

  MAUDE report 10030815 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF CR150 RP KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9851295 ↗