BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 23886577 · Received December 24, 2025

    Report

    Report Number
    3005180920-2025-01326
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 17, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720007
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-DEC-2025. LOT 2502524: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APR-2025 EXPIRATION DATE: 2030-04-07. 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 1 MONTH FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN THAT WAS THE RESULT OF A PERIPROSTHETIC FRACTURE. THE SURGEON CABLED THE FRACTURE, AND REVISED THE STEM TO A M-VIZION STEM AND THE HEAD TO AN IDENTICAL ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058887 AMISTEM-P AMISTEM-P STD. SIZE 1 LZO MEDACTA INTERNATIONAL SA 01.18.401 2502524 07630040720007

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention