BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 21643590 · Received March 19, 2025

    Report

    Report Number
    3005180920-2025-00186
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030804144
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-02-2025 LOT 174366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-11-2017. EXPIRATION DATE: 2022-10-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT (8 AS LOT 174366A) HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 6 YEARS AND 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING THIGH PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456976 AMISTEM H FEMORAL STEMS HIP STEM: AMISTEM-H STD. SIZE 8 MEH MEDACTA INTERNATIONAL SA 01.18.138 174366 07630030804144

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention