BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 25313931 · Received May 28, 2026

    Report

    Report Number
    3005180920-2026-00519
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040729147
    PMA / PMN Number
    K191816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MAY 2026 STEM: M-VIZION 01.22.168 DISTAL STEM D 19MM L 220MM STRAIGHT (K191816) LOT 2200653: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 02-JUN-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. STEM: M-VIZION 01.22.402 PROXIMAL BODY D 20MM L 50MM STD WITH HOLES (K201471) LOT 2338522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2024. EXPIRATION DATE: 23-JAN-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. LOT 2574493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. PRELIMINARY EVALUATION PERFORMED BY R&D PROJECT MANAGER BASED ON THE EVENT DESCRIPTION AND DETAILS PROVIDED: A REVISION PROCEDURE WAS PERFORMED, WITH THE OBJECTIVE OF CHANGING THE PROXIMAL BODY. INTRAOPERATIVELY, SEPARATION OF THE MODULAR PROXIMAL BODY FROM THE STEM COULD NOT BE ACHIEVED, AS THE EXTRACTION INSTRUMENTS WERE UNABLE TO DISENGAGE THE MODULAR TAPER JUNCTION. OCCURRENCES OF THIS NATURE HAVE BEEN REPORTED INFREQUENTLY AND PREDOMINANTLY IN RE-REVISION SURGERIES CONDUCTED A CONSIDERABLE TIME AFTER THE INDEX IMPLANTATION. FROM A TECHNICAL STANDPOINT, IT IS CONSIDERED THAT THE INTERACTION BETWEEN DIMENSIONAL TOLERANCES OF THE MATING TAPER COMPONENTS, IN COMBINATION WITH LONG-TERM IN VIVO LOADING CONDITIONS, MAY CONTRIBUTE TO AN INCREASED INTERFERENCE FIT AT THE MODULAR INTERFACE. OVER TIME, PHYSIOLOGICAL CYCLIC LOADING MAY FURTHER ENHANCE THE MECHANICAL LOCKING EFFECT AT THE TAPER JUNCTION. IN SUCH CIRCUMSTANCES, THE EXTRACTION FORCES REQUIRED TO DISENGAGE THE MODULAR CONNECTION MAY EXCEED THE STRUCTURAL CAPACITY OF THE CURRENTLY AVAILABLE REVISION INSTRUMENTS. A TECHNICAL IMPROVEMENT OF THE EXTRACTION INSTRUMENTATION IS CURRENTLY ONGOING TO INCREASING MECHANICAL RESISTANCE BE ABLE TO APPLY AN HIGHER FORCE TO THE IMPLANT TAPER IN HIGH-LOAD DISENGAGEMENT SCENARIOS. ROOT CAUSE: THE CONDITIONS OF SURGICAL VARIATION LIKELY RESULTED IN THE APPLIED FORCES EXCEEDING THE INHERENT LIMITATIONS OF THE DEVICE RESISTANCE AS CONSTRAINED BY THE COLLECTIVE DESIGN INPUTS. THERE IS NO POTENTIAL MANUFACTURING RELATED CAUSE INDICATED, HOWEVER A POTENTIAL FOR DESIGN OPTIMIZATION COULD BE ASSOCIATED.

    Description of Event or Problem · 0

    DURING A REVISION SURGERY PERFORMED ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, IT WAS NOT POSSIBLE TO SEPARATE THE PROXIMAL BODY FROM THE DISTAL STEM. INSTRUMENTS FOR REMOVAL DEFORMED DURING THE ATTEMPTS. AS THE ORIENTATION OF THE PROXIMAL BODY COULD NOT BE CHANGED, THE SURGEON DECIDED TO REVISE THE COMPETITOR`S CUP TO ADDRESS THE RISK OF JOINT LUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462639 M-VIZION FEMORAL REVISION SYSTEM DISTAL STEM Ø19MM L 220MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.168 2200653 07630040729147

    Patients

    Seq Age Sex Outcome Treatment
    1