BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL CEMENTLESS STEM SIZE 5 LAT

    MDR report key: 3724313 · Received December 18, 2013

    Report

    Report Number
    3005180920-2013-00169
    Event Type
    Injury
    Date Received
    December 18, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 5 LAT: REF. 01.12.035 / LOT 071203 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4). FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED, BUT THE INITIAL ACCIDENT IS LIKELY THE CAUSE OF THE SUBSIDENCE OF THE STEM.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662607 QUADRA H FEMORAL CEMENTLESS STEM SIZE 5 LAT FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1