BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISPACER 54MM X 4MM MED RT

    MDR report key: 506891 · Received January 16, 2004

    Report

    Report Number
    2935620-2004-00004
    Event Type
    Injury
    Date Received
    January 16, 2004
    Date of Event
    September 1, 2003
    Report Date
    January 16, 2004
    Manufacturer
    CENTERPULSE ORTHOPEDICS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PT WAS REVISED IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISPACER 54MM X 4MM MED RT KNEE PROSTHESIS HSH CENTERPULSE ORTHOPEDICS, INC. NA 1519197

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization