BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COLLARED FEMORAL STEM

    MDR report key: 3456514 · Received October 24, 2013

    Report

    Report Number
    3005180920-2013-00129
    Event Type
    Injury
    Date Received
    October 24, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    KWY
    PMA / PMN Number
    K121011
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H COLLARED FEMORAL STEM SIZE 2 LAT - REF. 01.18.142 / LOT 124023 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546033 AMISTEM H COLLARED FEMORAL STEM FEMORAL STEM SIZE 2 LAT CEMENTLESS KWY MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1