BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION TIBIAL BASEPLATE

    MDR report key: 183174 · Received August 20, 1998

    Report

    Report Number
    1644408-1998-00003
    Event Type
    Other
    Date Received
    August 20, 1998
    Date of Event
    January 1, 1996
    Report Date
    August 1, 1998
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT AT 17 MOS POSTOP EXPERIENCED PAIN. XRAYS SHOWED THAT THE TIBIAL ATTACHMENT SCREW HAD BECOME LOOSE AND HAD DISSASSOCIATED FROM THE TIBIAL PROSTHESES. REVISION SURGERY USING ENCORE IMPLANTS WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION TIBIAL BASEPLATE Implant TIBIAL STEMMED BASEPLATE JWH ENCORE ORTHOPEDICS, INC. * 55701

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention