BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 24710798 · Received March 30, 2026

    Report

    Report Number
    3005180920-2026-00252
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 27, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720311
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 MARCH 2026: STEM: AMISTEM-P COLLARED 01.18.442 AMISTEM-P COLLARED LAT. SIZE 2 (K173794) LOT 2005826: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2020. EXPIRATION DATE: 19-OCT-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE AMISTEM-P SIZE 2 STEM TO A SIZE 3 AND REVISED THE 40 MM BIOLOX HEAD TO A SAME SIZE BIOLOX HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770925 AMISTEM-P COLLARED AMISTEM-P COLLARED LAT. SIZE2 LZO MEDACTA INTERNATIONAL SA 01.18.442 2005826 07630040720311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention