BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIB B/P SZ4 UNI-KNEE

    MDR report key: 518284 · Received March 30, 2004

    Report

    Report Number
    2935620-2004-00034
    Event Type
    Injury
    Date Received
    March 30, 2004
    Date of Event
    February 12, 2004
    Report Date
    March 30, 2004
    Manufacturer
    CENTERPULSE ORTHOPEDICS, INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS REVISED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIB B/P SZ4 UNI-KNEE KNEE PROSTHESIS HRY CENTERPULSE ORTHOPEDICS, INC. NA 1379990

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization POR UNI FEMORAL SZ 4 NKII (LOT# UNK) (2004)| TIB INS SZ 3/4 9MM UNI-KNEE (LOT# UNKNOWN) (2004).