BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 22043492 · Received May 19, 2025

    Report

    Report Number
    3005180920-2025-00436
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040728928
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2025: LOT 2339009: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/03/2024. EXPIRATION DATE: 06/02/2029. 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 INSTRUMENT INVOLVED, BATCH REVIEW PERFORMED ON 29 APRIL 2025: LOT 2115471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21/03/2022. EXPIRATION DATE: 06/03/2027. 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. IT IS MOST LIKELY RELATED TO THE UNIQUE PATIENT/APPLICATION SPECIFIC CONDITIONS ASSOCIATED WITH THIS CASE, BUT THE CIRCUMSTANCES CANNOT BE CONFIRMED. THE INVESTIGATION RESULTS DO NOT INDICATE ANY POTENTIAL MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    DURING THE REVISION SURGERY DUE TO PAIN, PERFORMED ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, IT WAS NOTED THAT THE PROXIMAL BODY WAS RETROVERTED. THE PROXIMAL BODY WOULD NOT DISENGAGE FROM THE STEM. AN ATTEMPT AND MANUAL DISENGAGEMENT RESULTED IN THE ENTIRE CONSTRUCT EXTRACTION. THE CONSTRUCT WAS THEN REINSERTED WITH THE PROPER VERSION. REDUCTION WAS DIFFICULT AND RESULTED IN A NEW DISTAL FEMUR FRACTURE. 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. FRACTURE FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142920 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| O