BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENT LESS STEM SIZE 4 STD

    MDR report key: 4143497 · Received August 21, 2014

    Report

    Report Number
    3005180920-2014-00111
    Event Type
    Injury
    Date Received
    August 21, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 4 STD: REF. 01.18.134 / LOT 091145 ((B)(4) STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. TWENTY STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE INFORMATION COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505133 AMISTEM H FEMORAL CEMENT LESS STEM SIZE 4 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1