BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS TOTAL KNEE SYSTEM

    MDR report key: 175330 · Received June 29, 1998

    Report

    Report Number
    1020279-1998-00009
    Event Type
    Injury
    Date Received
    June 29, 1998
    Date of Event
    August 25, 1997
    Report Date
    January 23, 1998
    Manufacturer
    SMITH & NEPHEW INC. ORTHOPAEDICS DIV.
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, INITIALLY IMPLANTED 07/30/1996, BROKE AND REQUIRED REVISING ON 08/25/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS TOTAL KNEE SYSTEM Implant TIBIAL INSERT HSH SMITH & NEPHEW INC. ORTHOPAEDICS DIV. NA 4X21137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R