BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C FEMORAL STEMS

    MDR report key: 24454895 · Received February 26, 2026

    Report

    Report Number
    3005180920-2026-00159
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804304
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 FEBRUARY 2026. STEM: AMISTEM C 01.18.155 AMISTEM-C STD. SIZE 5 (K103189) LOT 182730: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2018. EXPIRATION DATE: 24-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 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 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AS THE RESULT OF A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM TO A COMPETITOR STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519759 AMISTEM C FEMORAL STEMS AMISTEM-C STD. SIZE 5 LZO MEDACTA INTERNATIONAL SA 01.18.155 182730 07630030804304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention