BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 25313929 · Received May 28, 2026

    Report

    Report Number
    3005180920-2026-00520
    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
    07630971263512
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MAY 2026 STEM: M-VIZION 01.22.402 PROXIMAL BODY D 20MM L 50MM STD WITH HOLES (K201471) LOT 2338522: 29 ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2024. EXPIRATION DATE: 23-JAN-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH OF THE SCREW SEMIFINISHED LOT (IT IS UNKNOWN WHICH ONE OF THE TWO IS INVOLVED): SCREW: M-VIZION 71.08.251 LOCKING SCREW - SEMIFINISHED LOT 2012662: 2250 ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. SCREW: M-VIZION 71.08.251 LOCKING SCREW - SEMIFINISHED LOT 2012662: 998 ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. R&D INVESTIGATION BASED ON INFORMATION PROVIDED REVISION PROCEDURE WAS PERFORMED DUE TO DISLOCATION, WITH THE OBJECTIVE OF CHANGING THE PROXIMAL BODY. DURING THE REVISION, THE SCREW THAT SECURES THE MODULAR CONNECTION WAS FOUND LOOSE. THE SCREW MAY HAVE LOOSENED AS A CONSEQUENCE OF A SETTLING PROCESS AT THE CONICAL CONNECTION BETWEEN THE PROXIMAL AND DISTAL COMPONENTS OF THE MODULAR HIP STEM. IN THIS CONTEXT, “SETTLING” REFERS TO A SLIGHT MICRO-ADJUSTMENT OR PROGRESSIVE SEATING OF THE TAPERED MATING SURFACES UNDER CYCLIC LOADING. DURING PATIENT ACTIVITY, THE BODY WEIGHT IS REPEATEDLY TRANSFERRED THROUGH THE STEM, GENERATING CYCLIC LOADS AT THE MODULAR JUNCTION. THESE LOADS MAY PROMOTE A MINOR STABILIZATION OF THE CONICAL INTERFACE, AS THE TWO TAPERED SURFACES PROGRESSIVELY REACH A MORE STABLE CONTACT CONDITION. THIS SETTLING PROCESS COULD BE RELATED TO AN ASSEMBLY SEQUENCE OF THE MODULAR COMPONENTS THAT WAS NOT FULLY OR PROPERLY COMPLETED. HOWEVER, BASED ON THE AVAILABLE INFORMATION, THIS CANNOT BE CONFIRMED AND REMAINS IMPOSSIBLE TO DETERMINE WITH CERTAINTY. THE SCREW DOES NOT HAVE A PRIMARY ROLE IN LOCKING THE PROXIMAL AND DISTAL COMPONENTS TOGETHER. THE MAIN MECHANICAL FIXATION IS PROVIDED BY THE CONICAL CONNECTION ITSELF. MECHANICAL FATIGUE TESTS WERE PERFORMED WITHOUT THE SCREW INSTALLED: THE STEM DID NOT SHOW ANY REDUCTION IN FATIGUE PERFORMANCE OR DURABILITY DURING THESE TESTS. AT PRESENT, THIS PHENOMENON APPEARS TO BE VERY RARE. THEREFORE, NO FURTHER ACTIONS ARE CURRENTLY ONGOING. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. THE SCREW LOOSENING MAY POSSIBLY BE ASSOCIATED WITH SETTLING AT THE MODULAR CONICAL CONNECTION, POTENTIALLY INFLUENCED BY AN ASSEMBLY SEQUENCE OF THE MODULAR COMPONENTS THAT MAY NOT HAVE BEEN FULLY COMPLETED, ALTHOUGH THIS CANNOT BE CONFIRMED. THIS IS A VERY ISOLATED SCENARIO AND NO INDICATION OF A SYSTEMIC DEVICE ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    PRIMARY SURGERY PERFORMED ON (B)(6) 2025. REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO JOINT LUXATION INVOLVING COMPETITOR` COMPONENTS (HEAD, LINER AND CUP FROM COMPETITOR). DURING THE REVISION, THE LOCKING SCREW WAS FOUND LOOSE. THE SAME LOCKING SCREW WASRETIGHTENED. IN ADDITION, AS THE PROXIMAL BODY COULD NOT BE SEPARATED FROM THE DISTAL STEM, THE SURGEON DECIDED TO REVISE THE ACETABUL COMPETITOR`S COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524050 M-VIZION FEMORAL REVISION SYSTEM PROXIMAL BODY Ø20MM L 50MM STD WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.402 2338522 07630971263512

    Patients

    Seq Age Sex Outcome Treatment
    1