P.F.C. SIGMA 96-0889Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295234425), received between May 11, 2021 and Sep 7, 2021 — 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 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. SURGEON NOTED LOOSENING OF THE PFC SIGMA FEMORAL ADAPTER AND PFC SIGMA BOLT. THE BOLT BROKE AND DISASSOCIATED FROM THE ADAPTER. THE FEMUR WAS EASILY REMOVED AND THE ADAPTER WAS TURNED LOOSE. THE REMAINING BOLT WAS REMOVED FROM THE EXISTING FEMORAL SLEEVE VIA A THREADED EXTRACTOR IN THE REVISION KNEE REMOVAL SYSTEM. ALL COMPONENTS WERE REMOVED. THE SURGEON THEN SUCCESSFULLY COMPLETED CONVERTING TO A HINGE FEMUR. PATIENT HAD EXISTING TC3 REVISION CONSTRUCT IN LEFT KNEE. DOI: (B)(6) 2017, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12437023 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE ROTATION OF IMPLANTS. NO LOOSENING WAS REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11804830 ↗