BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMISTEM C FEMORAL STEMS

    MDR report key: 22529151 · Received July 17, 2025

    Report

    Report Number
    3005180920-2025-00682
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030804274
    PMA / PMN Number
    K103189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JUN 2025. STEM: AMISTEM C 01.18.152 AMISTEM-C STD. SIZE 2 (K103189) LOT. 2421583: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2024. EXPIRATION DATE: 2029-09-20. 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. CLINICAL EVALUATION: THE AVAILABLE X-RAY IMAGES ARE PREOPERATIVE AND THEREFORE, NOT RELEVANT TO THE ANALYSIS OF THE EVENT THAT OCCURRED. ROOT CAUSE: THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE. ALTHOUGH NO SPECIFIC ROOT CAUSE CAN BE CONFIRMED, THE ISSUE EXPERIENCED IS LIKELY RELATED TO THE UNIQUE PATIENT CONDITIONS AND SURGICAL APPLICATION.

    Description of Event or Problem · 0

    DURING FEMUR PREPARATION WITH BROACH SIZE 2, THE AMISTEM-C STD. SIZE 2 REMAINED SAT UP (8 MM) AND COULD NOT BE INSERTED. THE STEM WAS REMOVED, THE CEMENT WAS REMOVED USING A DRILL, AND A SMALLER SIZE 0 WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME 2 HOURS (TOTAL SURGERY TIME 6 HOURS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808516 AMISTEM C FEMORAL STEMS AMISTEM-C STD. SIZE 2 JDI MEDACTA INTERNATIONAL SA 01.18.152 2421583 07630030804274

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other