BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H SIZE 2 STD

    MDR report key: 3393466 · Received October 3, 2013

    Report

    Report Number
    3005180920-2013-00111
    Event Type
    Injury
    Date Received
    October 3, 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 2 STD - REF. 01.18.132 / LOT 102666 (42 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 42 STEMS BELONGING TO THIS LOT 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.

    Description of Event or Problem · 1

    PLEASE REFER TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500742 AMISTEM H SIZE 2 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1