BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 25077231 · Received May 5, 2026

    Report

    Report Number
    3005180920-2026-00389
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 5, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 APRIL 2026 STEM: AMISTEM H 01.18.132 AMISTEM-H STD. SIZE 2 (K093944) LOT: 166415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2017. EXPIRATION DATE: 26-FEB-2022. 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 8 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR FALL. THE SURGEON REVISED THE MEDACTA HOODED D 32/D LINER TO A FLAT D 32/D LINER AND REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538180 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 2 LZO MEDACTA INTERNATIONAL SA 01.18.132 166415 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention