BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P STD STEM SIZE 3

    MDR report key: 12688361 · Received October 25, 2021

    Report

    Report Number
    3005180920-2021-00833
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 29, 2021
    Report Date
    October 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720021
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2021: LOT 1910410: 45 ITEMS MANUFACTURED AND RELEASED ON 02-APR-2020. EXPIRATION DATE: 2025-03-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 42 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM 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
    1591057 AMISTEM-P STD STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.403 1910410 07630040720021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention