BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS I CRUCIATE-RETAINING TIBIAL INSERT

    MDR report key: 178765 · Received July 23, 1998

    Report

    Report Number
    1020279-1998-00012
    Event Type
    Injury
    Date Received
    July 23, 1998
    Date of Event
    October 22, 1997
    Report Date
    February 27, 1998
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDICS DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES, INITIALLY IMPLANTED ON MARCH 24, 1995, REQUIRED REVISION ON OCTOBER 22, 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS I CRUCIATE-RETAINING TIBIAL INSERT Implant KNEE PROSTHESIS HSH SMITH & NEPHEW, INC. ORTHOPAEDICS DIV. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R