BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C FEMORAL STEM

    MDR report key: 3465920 · Received October 31, 2013

    Report

    Report Number
    3005180920-2013-00135
    Event Type
    Injury
    Date Received
    October 31, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103189
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM C FEMORAL STEM SIZE 0 STD CEMENTED - REF. (B)(4) / LOT 131652 (18 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. THE 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 DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559203 AMISTEM C FEMORAL STEM FEMORAL STEM SIZE 0 STD CEMENTED LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1