BEUDAMED
    FDA Adverse Event Summary report: N

    GENESIS TOTAL KNEE SYSTEM

    MDR report key: 175331 · Received June 29, 1998

    Report

    Report Number
    1020279-1998-00006
    Date Received
    June 29, 1998
    Date of Event
    November 7, 1997
    Report Date
    December 12, 1997
    Manufacturer
    SMITH & NEPHEW INC. ORTHOPAEDICS DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INITIALLY IMPLANTED ON DECEMBER 22, 1995 REQUIRED REVISION ON NOVEMBER 7, 1997.

    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 3A54452

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 1. 724841, LOT # 51103875.| 2. 124420, LOT # 5505367.