BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICON/GENESIS KNEE

    MDR report key: 129488 · Received October 30, 1997

    Report

    Report Number
    1020279-1997-00045
    Event Type
    Injury
    Date Received
    October 30, 1997
    Date of Event
    August 1, 1997
    Report Date
    October 30, 1997
    Manufacturer
    SMITH & NEPHEW INC. ORTHOPAEDICS DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INITIALLY IMPLANTED IN 07/1994 WAS REVISED IN 08/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRICON/GENESIS KNEE Implant TIBIAL ARTICULAR INSERT HSH SMITH & NEPHEW INC. ORTHOPAEDICS DIV. NA 4A67161

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R