BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. MODULAR KNEE SYSTEM FEMORAL COMPONENT-POROUS

    MDR report key: 65915 · Received February 3, 1997

    Report

    Report Number
    1219655-1997-00008
    Event Type
    Injury
    Date Received
    February 3, 1997
    Date of Event
    December 19, 1996
    Report Date
    February 3, 1997
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3, H6 - ONE 86-4109 P.F.C. FEMORAL KNEE WAS RECEIVED FOR NON-DESTRUCTIVE VISUAL ANALYSIS. THE DEVICE FRACTURED TRANSVERSELY THROUGH THE POSTERIOR DISTAL CHAMFER ON THE MEDIAL CONDYLE. VISUAL EXAMINATION OF THE FRACTURE SURFACE REVEALED IT TO BE A FATIGUE FAILURE. NO MATERIAL OR MFG DEFECTS WERE EVIDENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO FRACTURE OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. MODULAR KNEE SYSTEM FEMORAL COMPONENT-POROUS Implant POROUS FEMORAL COMPONENT HSA JOHNSON & JOHNSON PROFESSIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention