BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 22643026 · Received July 29, 2025

    Report

    Report Number
    3005180920-2025-00718
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263574
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-JUL-2025: STEM: M-VIZION 01.22.408 PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES (K201471) LOT. 2241140: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-03-2023 EXPIRATION DATE: 2028-02-09. 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. STEM: M-VIZION 01.22.163 DISTAL STEM Ø14MM L 220MM STRAIGHT (K191816) LOT. 2007071: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-03-2021 EXPIRATION DATE: 2026-02-23. 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. THE CAUSE OF THE REVISION IS REPORTED TO BE SPECIFIC DEVICE PLACEMENT IN THE PRIMARY SURGERY. 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 POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 1 WEEK FROM PRIMARY THE PATIENT UNDERWENT REVISION SURGERY DUE TO A MALPOSITIONING OF THE DISTAL STEM (FALSA VIA). THE ENTIRE CONSTRUCT HAS BEEN REVISED. THE TWO PARTS COULD NOT BE SEPARATED AS THE TIP OF THE SCREWDRIVER USING DURING PRIMARY BROKE INSIDE THE LOCKING SCREW. DURING THE TIGHTENING OF THE LOCKING SCREW THE SCREW DRIVER TIP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086678 M-VIZION FEMORAL REVISION SYSTEM M-VIZION PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.408 2241140 07630971263574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention