BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23510668 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01087
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 22, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27-10-2025 LOT 141478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2014 EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD (1 AS 141478A AND 1 AS 141478B) WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS A 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. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 11 YEARS AND 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616120 AMISTEM H FEMORAL STEMS AMISTEM-H LAT. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.143 141478 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention