BEUDAMED
    FDA Adverse Event Other Summary report: N

    NATURAL-KNEE II POR STM TIB B/P RT SZ3

    MDR report key: 167204 · Received May 13, 1998

    Report

    Report Number
    2935620-1998-00017
    Event Type
    Other
    Date Received
    May 13, 1998
    Date of Event
    April 13, 1998
    Report Date
    May 13, 1998
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISED LIBIAL COMPONENT DUE TO PAIN. PER SALES REP, THE DOCTOR REQUESTED SULZER ORTHOPEDICS TO EVALUATE THE COMPONENT FOR BONE IN-GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II POR STM TIB B/P RT SZ3 Implant KNEE TIBIAL PROSTHESIS HSH SULZER ORTHOPEDICS, INC. NA 1246208

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R