BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COLLARED FEMORAL STEMS

    MDR report key: 24321116 · Received February 12, 2026

    Report

    Report Number
    3005180920-2026-00096
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804694
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2 JANUARY 2026. STEM: AMISTEM COLLARED 01.18.244 AMISTEM COLLARED HA COATED STEM SIZE 4 LAT (K121011) LOT: 179409: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2018. EXPIRATION DATE: 02-APR-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 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 6 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386840 AMISTEM H COLLARED FEMORAL STEMS AMISTEM COLLARED HA COATED STEM SIZE 4 LAT LZO MEDACTA INTERNATIONAL SA 01.18.244 179409 07630030804694

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention