BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COLLARED FEMORAL STEMS

    MDR report key: 25160336 · Received May 13, 2026

    Report

    Report Number
    3005180920-2026-00449
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804571
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 APRIL 2026 STEM: AMISTEM COLLARED 01.18.232 AMISTEM COLLARED HA COATED STEM SIZE 2 STD (K121011) LOT 180785: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2018. EXPIRATION DATE: 06-JUN-2023. 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: ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP 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 AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR DEVICES AND REPLACED THE MEDACTA LINER WITH A SAME-SIZE LINER.THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTS OF TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48193 AMISTEM H COLLARED FEMORAL STEMS AMISTEM COLLARED HA COATED STEM SIZE 2 STD LZO MEDACTA INTERNATIONAL SA 01.18.232 180785 07630030804571

    Patients

    Seq Age Sex Outcome Treatment
    1