BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H SIZE 3 STD

    MDR report key: 3350350 · Received September 6, 2013

    Report

    Report Number
    3005180920-2013-00102
    Event Type
    Injury
    Date Received
    September 6, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 3 STD- REF. 01.18.133 / LOT 130595 (70 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. THE 48 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO OTHER INCIDENTS HAVE BEEN ALREADY IMPLANTED AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, WE DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED, BUT IT IS MORE LIKELY TO A MISTAKE DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444445 AMISTEM H SIZE 3 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1