BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3022521 · Received March 21, 2013

    Report

    Report Number
    3005180920-2013-00024
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 4 STD - REF. 01.18.134 / LOT 111233 (60 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. FIFTY THREE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE CAUSE OF THE SUBSIDENCE IS UNK AND WE DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO SUBSIDENCE OF THE STEM AMISTEM H. THE EVENT WAS DETECTED 6 MONTHS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117650 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 4 STD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA 111233

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention