BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY UNI TIBIAL BASE RM/LL SZ 4

    MDR report key: 6122937 · Received November 22, 2016

    Report

    Report Number
    1020279-2016-00899
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    November 8, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSX
    PMA / PMN Number
    K052265
    Removal / Correction Number
    Z-0925-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR UNSPECIFIED REASONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIBIA BASEPLATE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771223 JOURNEY UNI TIBIAL BASE RM/LL SZ 4 PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER HSX SMITH & NEPHEW, INC. 09AM15872

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R