BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD

    MDR report key: 3599097 · Received January 8, 2014

    Report

    Report Number
    3005180920-2013-00182
    Event Type
    Injury
    Date Received
    January 8, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 3 LAT: REF. (B)(4) / LOT 091356 ((B)(4)STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. THE (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUT CC PE LINER (K103352) REF. (B)(4) / LOT 112481 ((B)(4) LINER PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. THE 61 LINER BELONGING TO THIS LOT HAS ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC LIGHT CUP - NOT MARKETED IN THE USA REF. (B)(4) / LOT 113294 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. ALL THE CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. CERAMIC BIOLOX DELTA BALL HEAD NOTHING 28 SIZE S: REF. (B)(4) LOT 716735 ((B)(4) ITEMS BOUGHT FOR DISTRIBUTION BY MEDACTA - NOT MARKETED IN THE USA). TO DATE, (B)(4) HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13558 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD FEMORAL CEMENTLESS STEM JDI MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1