BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 2 STD

    MDR report key: 4345606 · Received December 11, 2014

    Report

    Report Number
    3005180920-2014-00182
    Event Type
    Injury
    Date Received
    December 11, 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 STEM SIZE 2 STD: REF 01.18.132 / LOT 113860 960 DEVICES PRODUCES): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. ALL THE STEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. VERSAFITCUP CC TRIO CEMENTLESS SHELL (K103352): REF 01.26.45.0046 / LOT 111518 ((B)(4) DEVICES PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. TOTAL OF (B)(4) CUPS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. OTHER COMPONENTS: VERSAFITCUP CC LINER (K103352): REF 01.26.2839HCT / LOT 112884: (B)(4) ITEMS PRODUCED AND ALL SOLD WITHOUT ANY SIMILAR EVENT REPORTED. COCR FEMORAL HEAD (K072857): REF 01.25.011 / LOT 113712: 60 ITEMS PRODUCED AND (B)(4) SOLD WITHOUT ANY SIMILAR EVENT REPORTED. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803926 AMISTEM H CEMENTLESS STEM SIZE 2 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1