BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 24208602 · Received January 29, 2026

    Report

    Report Number
    3005180920-2026-00078
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 29, 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 19 JANUARY 2026. STEM: AMISTEM-HP 01.18.132 AMISTEM-H STD. SIZE 2 (K093944) LOT 122546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2012. EXPIRATION DATE: 31-JUL-2017. 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 ABOUT13 YEARS AND 3 MONTHSFROM THE PRIMARY, THE PATIENT CAME IN PRESENTING HIP PAIN AND A LOOSE STEM WAS DIAGNOSED AFTER X-RAYS AND A CT SCAN. THE SURGEON REVISED THE MEDACTA LINER TO A MEDACTA 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
    272957 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 2 LZO MEDACTA INTERNATIONAL SA 01.18.132 122546 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention