BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 208889 · Received February 3, 1999

    Report

    Report Number
    1020279-1999-00003
    Event Type
    Injury
    Date Received
    February 3, 1999
    Date of Event
    December 31, 1998
    Report Date
    January 4, 1999
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDICS DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, INITIALLY IMPLANTED IN JUNE 21, 1994, WORE AND REQUIRED REVISION ON DECEMBER 31, 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS Implant TIBIAL INSERT HSH SMITH & NEPHEW, INC., ORTHOPAEDICS DIV. NA 4X26553

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R