BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC MODULAR KNEE SYSTEM POROUS FEMORAL COMPONENT

    MDR report key: 57349 · Received December 23, 1996

    Report

    Report Number
    1219655-1996-00043
    Event Type
    Injury
    Date Received
    December 23, 1996
    Date of Event
    December 3, 1996
    Report Date
    December 23, 1996
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 86-4101 FEMORAL KNEE COMPONENT WAS RECEIVED FOR NON-DESTRUCTIVE VISUAL EVAL. THE DEVICE FRACTURED TRANSVERSELY THROUGH THE POSTERIOR, DISTAL CHAMBER OFTHE MEDIAL CONDYLE. VISUAL EXAMINATION OF THE FRACTURE SURFACE REVEALED IT TO BE A FATIGUE FAILURE, ORIGINATING FROM THE PROXIMAL SURFACE OF THE LATERAL RIM OF THE BEAD POCKET, THE REGION OF HIGHEST APPLIED STRESS IN THE COMPONENT.

    Description of Event or Problem · 1

    POROUS COATED FEMORAL COMPONENT REMOVED FROM PT'S RIGHT KNEE DUE TO FRACTURE OF THE COMPONENT AT MEDIAL POSTERIOR CHAMBER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention MI