BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STEM SIZE 0 LAT

    MDR report key: 4374711 · Received December 19, 2014

    Report

    Report Number
    3005180920-2014-00192
    Event Type
    Injury
    Date Received
    December 19, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM C CEMENTED STEM SIZE 0 LAT: REF. 01.18.100 / LOT 135058 ((B)(4) DEVICES PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) STEMS ON THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. CERAMIC HEAD - NOT MARKETED IN THE USA - MANUFACTURED BY (B)(4): CODE 38.49.7175.675.00 - LOT 7010912295: (B)(4) HEADS BOUGHT BY MEDACTA AND (B)(4) ALREADY SOLD, WITHOUT ANY SIMILAR ISSUE. CERAMIC LINER - NOT MARKETED IN THE USA - MANUFACTURED BY (B)(4): CODE 38.49.7178.525.20 - LOT 762801: (B)(4) LINERS BOUGHT BY MEDACTA AND ALL ALREADY SOLD, WITHOUT ANY SIMILAR ISSUE. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838209 AMISTEM C CEMENTED STEM SIZE 0 LAT FEMORAL CEMENTED STEM JDI MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK