BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 16MM

    MDR report key: 463659 · Received June 4, 2003

    Report

    Report Number
    2935620-2003-00112
    Event Type
    Injury
    Date Received
    June 4, 2003
    Date of Event
    June 20, 2002
    Report Date
    May 19, 2003
    Manufacturer
    CENTERPULSE ORTHOPEDICS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PATIENT WAS REVISED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 16MM KNEE PROSTHESIS HSH CENTERPULSE ORTHOPEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R