BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2858771 · Received November 26, 2012

    Report

    Report Number
    3005180920-2012-00075
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 3 STD - (B)(4) / LOT 091969 (76 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. ALL THE STEMS BELONG TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE CAUSE OF THE LOOSENING IS UNKNOWN AND WE DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED; THIS IS A KNOWN COMPLICATION OF THR.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF THE AMISTEM H. WE WERE INFORMED ON (B)(6) 2012 ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STANDARD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA 091969

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CERAMIC BALL HEAD NOT MARKETED IN USA.