BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 3 LAT

    MDR report key: 3804407 · Received April 25, 2014

    Report

    Report Number
    3005180920-2014-00046
    Event Type
    Injury
    Date Received
    April 25, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS STEM SIZE 3 LAT: REF. 01.18.143 / LOT 123319 ((B)(4) DEVICES PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION PROCEDURES. THE (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR ISSUE. FROM THE X-RAYS ANALYSIS, A BONE REABSORPTION HAS BEEN NOTICED. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251997 AMISTEM H CEMENTLESS STEM SIZE 3 LAT FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1