BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 21708063 · Received March 27, 2025

    Report

    Report Number
    3005180920-2025-00242
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 28, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263574
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MARCH 2025. LOT 2409210: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09/09/2024. EXPIRATION DATE: 20/08/2029. 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 ITEM INVOLVED IN THE EVENT: STEM: M-VIZION 01.22.134 DISTAL STEM Ø15MM L 180MM STRAIGHT (K191816) LOT. 2411112 LOT 2411112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16/07/2024. EXPIRATION DATE: 04/07/2029. 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. ROOT CAUSE: THE EVENT WAS CAUSED BY A SUBOPTIMAL SELECTION OF IMPLANT SIZES DURING 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 POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    M-VIZION STEM WAS IMPLANTED ON (B)(6) 2025. THE PATIENT NEEDED TO BE REVISED BECAUSE WAS EXPERIENCING PAIN, INSTABILITY AND LEG LENGTH DISCREPANCY, DUE TO A TOO SHORT PROXIMAL BODY IMPLANTED AT THE PRIMARY SURGERY. THE REVISION SURGERY TOOK PLACE 1 MONTH AFTER THE PRIMARY SURGERY AND THE PLAN WAS TO REVISE ONLY THE PROXIMAL BODY. HOWEVER, THE DISASSEMBLY ROD BENT DURING PROXIMAL STEM EXTRACTION FROM THE DISTAL BODY. DESPITE THE ATTEMPTS, THE PROXIMAL BODY COULD NOT BE REMOVED FROM THE DISTAL STEM, THEREFORE THE SURGEON DECIDED TO REMOVE THE ENTIRE STEM (PROXIMAL + DISTAL). THE REVISION SURGERY WAS ALSO TREATED WITH AN M-VIZION. HERE, THE SURGEON CHOSE A 16MM 180MM DISTAL STEM WITH A LONGER PROXIMAL BODY 20MM 70MM TO COMPENSATE FOR THE INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470714 M-VIZION FEMORAL REVISION SYSTEM PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.408 2409210 07630971263574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention