BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM SIZE 3 LATY SHORT NECK

    MDR report key: 4173708 · Received September 25, 2014

    Report

    Report Number
    3005180920-2014-00126
    Event Type
    Injury
    Date Received
    September 25, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 3 LAT SHORT NECK REF. 01.12.33SN / LOT 090822/T ((B)(4) STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597339 QUADRA H FEMORAL STEM SIZE 3 LATY SHORT NECK FEMORAL CEMENTLESS STEM LAT SHORT NECK JDI MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1