BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 20493575 · Received October 21, 2024

    Report

    Report Number
    3005180920-2024-00821
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    September 21, 2024
    Report Date
    October 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720205
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2024 LOT 2340490: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2024. EXPIRATION DATE: 2029-01-30. 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.

    Description of Event or Problem · 0

    REVISION DUE TO A PERIPROSTHETIC FEMUR FRACTURE AND THE CAUSE IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043563 AMISTEM-P COLLARED HIP STEM COLLARED CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.431 2340490 07630040720205

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention