BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NP FEM LT SZ3 NK II

    MDR report key: 508951 · Received January 30, 2004

    Report

    Report Number
    2935620-2004-00009
    Event Type
    Injury
    Date Received
    January 30, 2004
    Date of Event
    December 16, 2003
    Report Date
    January 30, 2004
    Manufacturer
    CENTERPULSE ORTHOPEDICS INC.
    Product Code
    HSA
    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 NP FEM LT SZ3 NK II KNEE PROSTHESIS HSA CENTERPULSE ORTHOPEDICS INC. NA 1498128

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization (LOT#1512398)2003,| 6275-02-609 POLY PAT SZ2/7MM NIKII| (LOT#1240724) 2003.| 6215-08-301 POR TIB SPCR LAT SZ3 8MM NKKI| (LOT#1503335) 2003,| (LOT#1412962) 2003,| 6307-00-230 NP STM TIB B/P LT SZ3 NKII| 6275-02-609 ULTRA TIB INS LT SX3/4/5 9MM NKII