BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 STD

    MDR report key: 3724706 · Received March 12, 2014

    Report

    Report Number
    3005180920-2014-00025
    Event Type
    Injury
    Date Received
    March 12, 2014
    Date of Event
    February 5, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 3 STD: REF. 01.12.023/LOT 132553 (B)(6): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(6). FROM THE ANALYSIS OF THE X-RAYS PERFORMED BY THE R&D MANAGER, IT SEEMS THAT THE SIZE INITIALLY CHOSEN WAS NOT CORRECT AND THIS IS HIGH LIKELY THE CAUSE OF THE SUBSIDENCE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148338 QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention