BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23615339 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01172
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7 NOVEMBER 2025. STEM: AMISTEM H 01.18.137 AMISTEM-H STD. SIZE 7 (K093944) LOT 157350: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2016. EXPIRATION DATE: 07-APR-2021. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 8 YEARS AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON NOTED NO BONE QUALITY ISSUES. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD. HE REVISED THE MEDACTA LINER TO A MEDACTA LINER. X-RAYS UNAVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024008 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 7 LZO MEDACTA INTERNATIONAL SA 01.18.137 157350 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention