BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION DISTAL STEM 12MM L 180MM STRAIGHT

    MDR report key: 12102010 · Received July 1, 2021

    Report

    Report Number
    3005180920-2021-00530
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 2, 2021
    Report Date
    July 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040728898
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 JUNE 2021: LOT 1901231: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-NOV-2019. EXPIRATION DATE: 2024-11-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE PROXIMAL BODY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994769 STEM: M-VIZION DISTAL STEM 12MM L 180MM STRAIGHT DISTAL HIP STEM LZO MEDACTA INTERNATIONAL SA 01.22.131 1901231 07630040728898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention