BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA TIB INS LT SZ3/4/5 13MM NK II

    MDR report key: 508941 · Received January 30, 2004

    Report

    Report Number
    2935620-2004-00008
    Event Type
    Injury
    Date Received
    January 30, 2004
    Date of Event
    August 6, 2003
    Report Date
    January 30, 2004
    Manufacturer
    CENTERPULSE ORTHOPEDICS INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PT WAS REVISED 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA TIB INS LT SZ3/4/5 13MM NK II KNEE PROSTHESIS HSH CENTERPULSE ORTHOPEDICS INC. NA 1453514

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization 6300-07-1002 POLY PAT SZ 2/7MM NII(LOT#1509773) 03