BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVEN REVISION KNEE

    MDR report key: 1030012 · Received April 14, 2008

    Report

    Report Number
    2530191-2008-00001
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    January 8, 2008
    Report Date
    April 14, 2008
    Manufacturer
    STELKAST INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO SURGEON FOLLOWING REVISION TKA WITH PAIN AND INFLAMMATION. RADIOGRAPHIC EXAMINATION APPEARS TO SHOW THAT THE TIBIAL TRAY IS SEPARATED FROM THE TIBIAL BUSHING AND STEM CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVEN REVISION KNEE JWH STELKAST INC. 14848-122005

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention