BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 24558228 · Received March 10, 2026

    Report

    Report Number
    3005180920-2026-00217
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 10, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 FEBRUARY 2026. STEM: AMISTEM H 01.18.131 AMISTEM-H STD. SIZE 1 (K093944) LOT 160640: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2016. EXPIRATION DATE: 21-APR-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE 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 9 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE WAS A LOOSE STEM. NO TRAUMA WAS REPORTED. THE SURGEON REVISED THE MEDACTA STEM AND MEDACTA HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE D 32 LINER TO A D 36 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620641 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 1 LZO MEDACTA INTERNATIONAL SA 01.18.131 160640 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention