BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 23837340 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01286
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720229
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 9 DECEMBER 2025. STEM: AMISTEM P 01.18.433 AMISTEM-P COLLARED STD. SIZE 3 (K173794) LOT 2112769: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2022. EXPIRATION DATE: 15-MAR-2027. 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 INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT1 YEAR 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274142 AMISTEM-P COLLARED AMISTEM-P COLLARED STD. SIZE3 LZO MEDACTA INTERNATIONAL SA 01.18.433 2112769 07630040720229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention