BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23510644 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01113
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 10, 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 27 OCTOBER 2025 STEM: AMISTEM H 01.18.132 AMISTEM-H STD. SIZE 2 (K093944) LOT 134165: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2013. EXPIRATION DATE: 30-SEP-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE 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 DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 10 YEARS FROM THE PRIMARY, REVISION SURGERY NEEDED DUE TO A LOOSE STEM. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM, HEAD AND CUP WITH COMPETITORS AND THE LINER WITH A NEW MEDACTA LINER (AN HOODED LINER INSTEAD OF THE FLAT LINER THAT WAS ORIGINALLY IMPLANTED).THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543359 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 2 LZO MEDACTA INTERNATIONAL SA 01.18.132 134165 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention