BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD III

    MDR report key: 192985 · Received October 20, 1998

    Report

    Report Number
    9612439-1998-00001
    Event Type
    Injury
    Date Received
    October 20, 1998
    Date of Event
    June 22, 1997
    Report Date
    November 5, 1997
    Manufacturer
    SMITH & NEPHEW INC. ORTHOPAEDICS DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, INITIALLY IMPLANTED ON 04/09/1992, WORE AND REQUIRED REVISION ON 11/05/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOD III Implant TIBIAL COMPONENT HSH SMITH & NEPHEW INC. ORTHOPAEDICS DIV. NA 199070

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R