BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 21503676 · Received March 3, 2025

    Report

    Report Number
    3005180920-2025-00153
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885006
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 FEB 2025: LOT 2006788: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2020. EXPIRATION DATE: 18-OCT-2025. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 18 FEB 2025: M-VIZION 01.22.402 PROXIMAL BODY Ø20MM L 50MM STD WITH HOLES (K201471) LOT 2007093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2021. EXPIRATION DATE: 13-APR-2026. 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

    AT ABOUT 3 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A NEW MEDACTA STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345091 M-VIZION FEMORAL REVISION SYSTEM M-VIZION DISTAL STEM Ø14MM L 140MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.103 2006788 07630030885006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention