BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 22114094 · Received May 30, 2025

    Report

    Report Number
    3005180920-2025-00486
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040728928
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MAY 2025: LOT 2115471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-03-2022. EXPIRATION DATE: 2027-03-06. 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. ADDITIONAL COMPONENT INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 12 MAY 2025. STEM: M-VIZION 01.22.429 PROXIMAL BODY Ø24MM L 60MM LAT WITH HOLES (K201471) LOT 2115471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-03-2024. EXPIRATION DATE: 2029-02-06. 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. 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

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. IT WAS NOTED THAT THE PROXIMAL BODY WAS RETROVERTED AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY ALL COMPONENTS WERE EXTRACTED INCLUDING THE NON-MEDACTA CUP/LINER. THE CASE WAS THEN CARRIED OUT WITH SUCCESS WITH A NEW M-VIZION STEM AND PROXIMAL BODY ALONG WITH A MEDACTA BIPOLAR HEAD CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13538 M-VIZION FEMORAL REVISION SYSTEM DISTAL STEM Ø15MM L 180MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.134 2339009 07630040728928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention