BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC CURVED TIBIAL INSERT

    MDR report key: 173703 · Received June 24, 1998

    Report

    Report Number
    1219655-1998-00114
    Event Type
    Injury
    Date Received
    June 24, 1998
    Date of Event
    March 17, 1998
    Report Date
    June 24, 1998
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONALS, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NON-DESTRUCTIVE VISUAL EXAMINATION WAS PERFORMED ON THE 86-4157 PFC TIBIAL INSERT WHICH WAS REVISED DUE TO SWELLING AND POLYETHYLENE WEAR. THE ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE INSERT SHOWED AREAS OF ADHESIVE/ABRASIVE WEAR HAVING A POLISHED AND TEXTURED APPEARANCE. THE INFERIOR SIDE OF THE INSERT HAD LIGHT BURNISHING OVER ABOUT 30-35% OF ITS SURFACE. THERE WERE NO APPARENT MATERIAL OR MFG DEFECTS NOTED ON THE COMPONENT. AT THIS TIME, JJPI CONSIDERS THIS FILE CLOSED.

    Description of Event or Problem · 1

    PT EXPERIENCED SWELLING IN KNEE. TIBIAL INSERT WAS REVISED DUE TO POLYTHYLENE WEAR. NOTE: ALL PLASTIC PATELLA (CODE UNK) ALSO REVISED, BUT NOT DUE TO FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC CURVED TIBIAL INSERT Implant PROSTHETIC KNEE-CURVED TIBIAL INSERT HSH JOHNSON AND JOHNSON PROFESSIONALS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention