BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 24429841 · Received February 24, 2026

    Report

    Report Number
    3005180920-2026-00129
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 29, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263598
    PMA / PMN Number
    K201471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 FEB 2026. (K201471) LOT: 2414755: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 NOV 2024. EXPIRATION DATE: 23 OCT 2029. ONE NONCONFORMITY AND TWO ANOMALIES WERE RECORDED; HOWEVER, NO ANOMALIES WERE CONFIRMED AS RELATED TO THE REPORTED ISSUE DURING THE BATCH REVIEW ACTIVITIES. TO DATE, (B)(4) ITEMS FROM THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR CONFIRMED EVENTS REPORTED FOR THIS LOT DURING THE PERIOD OF REVIEW. (K1706909) LOT: 2424966: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 NOV 2024. EXPIRATION DATE: 07 NOV 2029. TWO ANOMALIES WERE RECORDED; HOWEVER, NO ANOMALIES WERE CONFIRMED AS RELATED TO THE REPORTED ISSUE DURING THE BATCH REVIEW ACTIVITIES. TO DATE, (B)(4) ITEMS FROM THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR CONFIRMED EVENTS REPORTED FOR THIS LOT DURING THE PERIOD OF REVIEW. INVESTIGATION: REVISION SURGERY WAS PERFORMED TO REPLACE THE MEDACTA PROXIMAL BODY DUE TO INSTABILITY AND DISLOCATION, WITH THE AIM OF CORRECTING THE ROTATION AND IMPLANTING A PROXIMAL BODY 10 MM LONGER. HOWEVER, IT WAS NOT POSSIBLE TO DETACH THE MEDACTA PROXIMAL BODY FROM THE STEM BECAUSE THE DISASSEMBLY INSTRUMENTS BENT DURING THE PROCEDURE. THIS ISSUE OCCURS SPORADICALLY, PARTICULARLY IN RE-REVISION CASES PERFORMED TIME AFTER THE INITIAL STEM IMPLANTATION. IT IS LIKELY THAT, IN SOME CASES, A COMBINED EFFECT OF THE MANUFACTURING TOLERANCES OF THE TWO MATING COMPONENTS OF THE MODULAR TAPER RESULTS IN A HIGHER-THAN-NORMAL CONNECTION FORCE. THE FACT THAT SOME TIME PASSED AFTER THE FIRST IMPLANTATION, MEANS THAT THE MODULAR JUNCTION WAS FURTHER LOCKED BY THE WEIGHT OF THE PATIENT DURING WALKING, ETC. UNDER THESE CONDITIONS, DURING RE-REVISION PROCEDURES, THE CURRENT EXTRACTION INSTRUMENTS ARE NOT SUFFICIENTLY ROBUST TO DISENGAGE THE MODULAR JUNCTION.

    Description of Event or Problem · 0

    DURING THE ATTEMPTS OF REMOVAL OF THE PROXIMAL BODY FROM THE DISTAL STEM, THE PROXIMAL BODY HANDLE DEFORMED AND IT WAS NOT POSSIBLE TO DISCONNECT THE PROXIMAL BODY FROM THE DISTAL STEM. THE SURGEON LEFT THE CONSTRUCT IN PLACE WITH NO LOCKING SCREW AND PROCEEDED CHANGING ONLY THE HEAD. THIS EVENT HAPPENED DURING A REVISION SURGERY PERFORMED ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO INSTABILITY AND DISLOCATION. THE SURGEON WANTED TO CORRECT THE ROTATION OF THE PROXIMAL BODY AND TO IMPLANT A PROXIMAL BODY 10MM LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628848 M-VIZION FEMORAL REVISION SYSTEM PROXIMAL BODY Ø20MM L 70MM LAT WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.410 2414755 07630971263598

    Patients

    Seq Age Sex Outcome Treatment
    1