BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC MODULAR KNEE SYSTEM TIBIAL INSERT

    MDR report key: 49954 · Received November 20, 1996

    Report

    Report Number
    1219655-1996-00037
    Event Type
    Injury
    Date Received
    November 20, 1996
    Date of Event
    October 23, 1996
    Report Date
    November 19, 1996
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED LEFT KNEE PAIN. REVISION SURGERY FOUND DELAMINATION OF U H M W P E ON TIBIAL INSERT'S ARTICULATING SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC MODULAR KNEE SYSTEM TIBIAL INSERT Implant CURVED TIBIAL INSERT HSH JOHNSON & JOHNSON PROFESSIONAL INC. NA K470

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention