BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA KNEE

    MDR report key: 26905 · Received September 25, 1995

    Report

    Report Number
    33446-1995-00167
    Event Type
    Injury
    Date Received
    September 25, 1995
    Date of Event
    September 20, 1995
    Report Date
    September 21, 1995
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WEAR THROUGH & SEPARATION OF PATELLA POLY FROM METAL BACK. EXCESSIVE WEAR TO TIBIAL INSERT. REPLACED WITH 1G X 11MM TIBIAL INSERT & MED ALL POLY PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA KNEE Implant TOTAL KNEE JWH HOWMEDICA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization