BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23886578 · Received December 24, 2025

    Report

    Report Number
    3005180920-2025-01313
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 18, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-DEC-2025. LOT 143132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUL-2014 EXPIRATION DATE: 2019-06-30. 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 11 YEARS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FEMORAL FRACTURE. THE SURGEON CABLED AND PLATED THE FRACTURE. NO IMPLANTS WERE REVISED OR EXPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058888 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.133 143132 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention