BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM SIZE 3 LAT SHORT NECK

    MDR report key: 3268323 · Received July 26, 2013

    Report

    Report Number
    3006639916-2013-00090
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 26, 2013
    Manufacturer
    MEDACTA USA INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS COMPLAINING OF PAIN 1 YEAR AFTER INITIAL SURGERY IN (B)(6) 2011. THE SURGEON DID A BONE SCAN WHICH SHOWED A "HOT SPOT" ON THE PROXIMAL MEDIAL CORTEX. HE REVISED PATIENT AS THOUGH STEM WAS LOOSE. REFERENCE MFR REPORT NUMBER: 3005180920-2013-00090.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349850 QUADRA H CEMENTLESS STEM SIZE 3 LAT SHORT NECK CEMENTLESS FEMORAL STEM LZO MEDACTA USA INC. 100880

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other