BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS TOTAL KNEE SYSTEM

    MDR report key: 190737 · Received September 25, 1998

    Report

    Report Number
    1020279-1998-00031
    Event Type
    Injury
    Date Received
    September 25, 1998
    Date of Event
    May 8, 1998
    Report Date
    June 30, 1998
    Manufacturer
    SMITH & NEPHEW INC., ORTHOPAEDICS DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, INITIALLY IMPLANTED IN 1991, FRACTURED AND WAS REVISED ON 05/08/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS TOTAL KNEE SYSTEM Implant KNEE PROSTHESIS HSH SMITH & NEPHEW INC., ORTHOPAEDICS DIV. NA 4X26555

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R