BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 24494901 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00140
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 FEBRUARY 2026. LOT 112816: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2011. EXPIRATION DATE: 2016-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT 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

    AT ABOUT 10 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAINT DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450317 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 0 LZO MEDACTA INTERNATIONAL SA 01.18.130 112816 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention