BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM SIZE 2

    MDR report key: 7269586 · Received February 14, 2018

    Report

    Report Number
    3005180920-2018-00038
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 02 FEBRUARY 2018: HIP REVISION SURGERY OCCURRED 4 YEARS AFTER PRIMARY IMPLANTATION. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1 AND 2. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY THA AND CAUSES ARE OFTEN UNKNOWN. IN THIS CASE, THE REASON OF FAILURE CANNOT BE DETERMINED. CLINICAL EVALUATION PERFORMED ON 13 FEBRUARY 2018 BY R&D PRODUCT MANAGER: THE STEM WAS ANALYZED. SOME SIGNS WERE EVIDENT ON THE NECK, DUE TO THE REVISION SURGERY TO REMOVE THE STEM. THE HA COATING WAS TOTALLY ABSORBED. THERE ARE NO SIGNS THAT INDICATE A FAILURE OF THE DEVICE AND FROM THE RECEIVED PART IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. BATCH REVIEW PERFORMED ON 13 FEBRUARY 2018, LOT 120920: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2012. EXPIRATION DATE: 2017-04-30 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

    4 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112818 AMISTEM H HA COATED LAT STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 120920 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention