BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2964131 · Received February 8, 2013

    Report

    Report Number
    3005180920-2013-00001
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 3 STD - REF. 01.18.133 / LOT 122549 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4) 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 BONE FRACTURE IS UNK AND WE DO NOT HAVE EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    FEMUR FRACTURE OCCURRED 5 WEEKS POST OP. THE SURGEON PERFORMED 2 CERCLAGES AND CHANGED THE BALL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53757 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA 122549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention