BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 22479550 · Received July 11, 2025

    Report

    Report Number
    3005180920-2025-00636
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 11, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 JUNE 2025: LOT 170030: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18/05/2017. EXPIRATION DATE: 08/05/2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: A REVISION SURGERY WAS PERFORMED APPROXIMATELY SEVEN AND A HALF YEARS AFTER THE PRIMARY THA DUE TO STEM LOOSENING. THE AVAILABLE RADIOGRAPHIC IMAGES REVEAL RADIOLUCENT LINES, PREDOMINANTLY AROUND THE PROXIMAL PORTION OF THE STEM, ALONG WITH CORTICAL THICKENING AT ITS DISTAL END. ASEPTIC LOOSENING IS A WELL-DOCUMENTED COMPLICATION IN THE LITERATURE, FREQUENTLY PRESENTING WITH A MULTIFACTORIAL OR UNCLEAR ETIOLOGY. IN THIS CASE AS WELL, THE PRECISE CAUSE OF FAILURE CANNOT BE DEFINITIVELY ESTABLISHED BASED ON THE AVAILABLE CLINICAL AND RADIOGRAPHIC DATA. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AFTER 7 YEARS AND 5 MONTHS FROM THE PRIMARY X-RAYS SHOWED STEM LOOSENING. THE STEM WAS EASILY REMOVED AND THE SURGERY CONCLUDED SUCCESFULLY. HEAD AND LINER WERE ALSO REVISED PER STANDARD PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894119 AMISTEM H FEMORAL STEMS STEM: AMISTEM H 01.18.143 AMISTEM-H LAT. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.143 170030 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention