BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 1 STD

    MDR report key: 6039930 · Received October 19, 2016

    Report

    Report Number
    3005180920-2016-00530
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 30 SEPTEMBER 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ASEPTIC LOOSENING OF FEMORAL STEM IN CEMENTLESS THA 5 YEARS AFTER PRIMARY IN A YOUNG FEMALE PATIENT. ONLY ONE INTRAOPERATIVE FLUOROSCOPIC IMAGE IS SUPPLIED, WHICH BARELY SHOWS THE LOOSE STEM BUT NO OTHER CONSIDERATION CAN BE MADE AT THIS STAGE IN ABSENCE OF INFORMATION. BATCH REVIEW PERFORMED ON 17 OCTOBER 2016. LOT 103224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 DECEMBER 2010. EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THE STEM WAS LOOSE. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691679 AMISTEM H, HA COATED STEM SIZE 1 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 103224

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention