P.F.C. SIGMA 96-0821Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295234074), received between Sep 8, 2017 and Apr 13, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. IMPLANTS WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER WAS PERFORMED. DOI: (B)(6) 2015; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14104026 ↗
• InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6852471 ↗
• InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6852427 ↗