BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 197973 · Received November 16, 1998

    Report

    Report Number
    1020279-1998-00065
    Event Type
    Injury
    Date Received
    November 16, 1998
    Date of Event
    July 31, 1998
    Report Date
    November 10, 1998
    Manufacturer
    SMITH & NEPHEW, INC./ORTHOPAEDICS DIV
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, INITIALLY IMPLANTED ON 04/12/1995, WORE AND REQUIRED REVISION ON 07/31/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS Implant TIBIAL INSERT HSH SMITH & NEPHEW, INC./ORTHOPAEDICS DIV NA 4X22072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R