P.F.C. SIGMA 96-0782Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295233923), received between Apr 12, 2018 and Feb 5, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED A LEFT KNEE REVISION FOR FAILED REVISION ARTHROPLASTY. ADAPTER BOLT AND ADAPTER BROKEN. ADAPTER WAS NOT ABLE TO BE REMOVED FROM UNIVERSAL SLEEVE. THE SURGEON TRIED FOR 90 MINUTES TO REMOVE THE ADAPTER FROM THE SLEEVE BUT WAS UNSUCCESSFUL. THE SURGEON DECIDED TO TRANSFER THE PATIENT TO ANOTHER FACILITY FOR TREATMENT AND MOST LIKELY A DISTAL FEMORAL REPLACEMENT. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND HAD TO BE ABORTED AND PATIENT TRANSFERRED.

  Patient problems: Insufficient Information

  MAUDE report 21314664 ↗
• MalfunctionMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. AS I WAS LIVE ACCOMPANYING THE SURGERY, THE SURGEON COULD SPOT THE BROKEN SCREW INSIDE THE KNEE AND POINTED IT OUT TO ME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315554 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LAST (B)(6) 2021 DUE TO STAGE 1 INFECTION. SURGERY WAS DONE AT (B)(6)HOSPITAL. THE 1ST REVISION WAS DONE ON (B)(6) 2016. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12542216 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF A SIGMA TC3 REVISION KNEE PROSTHESIS FOR INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11091419 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2012; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9829037 ↗
• InjuryApr 12, 2018Fracture; Fracture

  SALES REP REPORT: A REPLACEMENT OF A RIGHT KNEE JOINT PROSTHESIS WILL BE PERFORM ON MONDAY (B)(6) 2018. THIS RIGHT KNEE JOINT PROSTHESIS (PRODUCT TC3 DEPUY) WAS IMPLANTED ON (B)(6) 2014 AND REPLACED ANOTHER RIGHT KNEE JOINT PROTHESIS BECAUSE THE PATIENT HAD MEDIAL FEMOROTIBIAL AND PATELLOFEMORAL PAINS. DOB : (B)(6).

  Patient problems: Not Applicable; Pain

  MAUDE report 7424932 ↗