BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23579952 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01130
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 18, 2025
    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 4 NOVEMBER 2025: LOT 150007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2015. EXPIRATION DATE: 2020-FEB-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 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

    REVISION SURGERY FOR STEM LOOSENING AT ABOUT 10 YEARS AND 5 MONTHS POST PRIMARY. ALL DEVICES REVISED SUCCESSFULLY. NO SIGNS OF INFECTION FOUND IN THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316972 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 2 LZO MEDACTA INTERNATIONAL SA 01.18.132 150007 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention