BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H SIZE 1 LAT

    MDR report key: 3486227 · Received November 8, 2013

    Report

    Report Number
    3005180920-2013-00139
    Event Type
    Injury
    Date Received
    November 8, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 1 LAT - REF. 01.18.141 / LOT 103233 (46 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THIRTY ONE 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

    REFERENCE IMPORTER REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578424 AMISTEM H SIZE 1 LAT FEMORAL CEMENTLESS STEM LPH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1