BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD II UNICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 190821 · Received September 25, 1998

    Report

    Report Number
    1020279-1998-00025
    Event Type
    Injury
    Date Received
    September 25, 1998
    Date of Event
    October 8, 1997
    Report Date
    April 6, 1998
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDICS DIV.
    Product Code
    HTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, INITIALLY IMPLANTED ON 12/12/1991 WORE AND REQUIRED REVISION ON 10/08/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOD II UNICOMPARTMENTAL KNEE SYSTEM Implant KNEE PROSTHESIS HTG SMITH & NEPHEW, INC., ORTHOPAEDICS DIV. NA 2X32750

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R