BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23655151 · Received November 26, 2025

    Report

    Report Number
    3005180920-2025-01190
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 10, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2025. LOT 103224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-DEC-2010. EXPIRATION DATE: 31-OCT-2015. 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 ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 13 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN THAT WAS DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM. THE SURGEON ALSO SWAPPED THE MEDACTA LINER FOR A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947428 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 1 LZO MEDACTA INTERNATIONAL SA 01.18.131 103224 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention