BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H HA COATED LAT STEM SIZE 2

    MDR report key: 7206137 · Received January 19, 2018

    Report

    Report Number
    3005180920-2017-00850
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED ON 22 DECEMBER 2017 BY MEDICAL AFFAIRS DEPARTMENT: APPROXIMATELY 6 YEARS AFTER PRIMARY CEMENTLESS THA THE FEMORAL STEM IS FOUND LOOSE AND REPLACED. THE ONE IMAGE SUPPLIED SHOWS SIGNIFICANT SIGNS OF STRESS SHIELDING AND DISTAL LOAD TRANSFER. THERE ARE NO PREVIOUS IMAGES THAT MAY HELP RECONSTRUCTING THE DEVELOPMENT OF THIS SITUATION. THE SIZING OF THE STEM TO THE FEMORAL BONE CANNOT BE EVALUATED HAVING ONLY THE PRE-REVISION XRAY IN ONE PROJECTION. THE ROOT CAUSE OF THIS ADVERSE EVENT CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER ON 16 JANUARY 2018: THE REVISED STEM APPEARED WITHOUT ANY PARTICULAR SIGN; HA COATING SEEMS TO BE TOTALLY ABSORBED AND BLOOD COATS SOME AREAS OF THE SURFACE. FROM THE RECEIVED IMAGE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. BATCH REVIEW PERFORMED ON 18 JANUARY 2018: LOT 112644: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPT 2011. EXPIRATION DATE: 2016-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY WAS NECESSARY 5 YEARS ANF 10 MONTHS AFTER PRIMARY DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49513 AMISTEM-H HA COATED LAT STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 112644 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention