BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM

    MDR report key: 4963982 · Received July 29, 2015

    Report

    Report Number
    3005180920-2015-00152
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    October 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 02 OCTOBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 27, 2015: LOT 150139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON APRIL 28, 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON JULY 14, 2015, THE (B)(4) MADE THE FOLLOWING EVAL, CHECKING THE X-RAYS RECEIVED WITH THE COMPLAINT. POSTOPERATIVE FRACTURE IS A KNOWN COMPLICATION FOR FEMORAL PROSTHESES, EVEN MORE SO IN CASE OF UNCEMENTED STEMS. IT IS POSSIBLE THAT THE INITIAL CAUSE OF THE FRACTURE IS A WEAKENING OF THE FEMUR DURING PREPARATION FOR INSERTION OF FEMORAL STEM, OR DURING INSERTION ITSELF, WHICH NORMALLY IS MADE BY IMPACTION. VERY OFTEN, THE SMALL CRACKS CAUSED DURING THE FIRST OPERATION GO UNDETECTED AND THEN PROPAGATE UNDER LOAD AND GENERATE MICROFRACTURE. FROM THE POSTOPERATIVE XRAY, IN THIS CASE OF AN ELDERLY PT, NO SIGN IS VISIBLE OF CRACK, BUT ON THE OTHER HAND NO MENTION OF A TRAUMA WAS MADE IN THE REPORT. HENCE, THE ROOT CAUSE IS NOT IDENTIFIABLE WITH THE INFO AVAILABLE.

    Description of Event or Problem · 1

    IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492673 AMISTEM H HA COATED LAT STEM CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1