P.F.C. SIGMA 96-0902Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295234487), received between Aug 2, 2018 and Jan 10, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Noise, Audible” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP IS REPORTING A FRACTURE OF THE FEMORAL TAPER COMPONENT.

  Patient problems: Joint Laxity

  MAUDE report 18484830 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI : (B)(6) 2008 DOR : (B)(6) 2022 LEFT SIDE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13335089 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI : (B)(6) 2008 DOR : (B)(6) 2022 LEFT SIDE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13335061 ↗
• InjuryDec 8, 2021Noise, Audible; Noise, Audible

  THIS PC WAS CREATED TO CAPTURE THE EVENT HAPPENED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD A LEFT KNEE ARTHROSCOPIC SYNOVECTOMY TO ADDRESS LEFT KNEE ARTHROFIBROSIS AFTER TOTAL KNEE. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD A PREVIOUS TOTAL KNEE, AND THEN LATER ON REQUIRED A REVISION TO A TC-III STYLE IMPLANT BY DEPUY. THE PATIENT DEVELOPED CATCHING OF HIS KNEE, SWELLING, AND RECURRENT HEMARTHROSIS. DURING THIS CURRENT PROCEDURE THE SURGEON OBSERVED PERIPATELLAR ARTHROFIBROSIS. (PAGE 106 OF 274) NO COMPONENTS WERE REVISED. NO OTHER INFO WAS PROVIDED. DOI: (B)(6) 2011. DOE: (B)(6) 2013. LEFT KNEE

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12961789 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS. REVISION WAS REQUIRED DUE TO INFECTION BEING PRESENT WITH SWELLING AND FLUID WITHIN THE KNEE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE.

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

  MAUDE report 11887208 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS. REVISION WAS REQUIRED DUE TO INFECTION BEING PRESENT WITH SWELLING AND FLUID WITHIN THE KNEE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE.

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

  MAUDE report 11887076 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11455627 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE REVISION OF KNEE ARTHROPLASTY. PATIENT CONSEQUENCE? UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION: PAIN AND DIFFICULT TO WALK. ACTION TAKEN FOR PROCEDURE:CULTURES TAKEN, IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Pain

  MAUDE report 7741911 ↗