BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 23477198 · Received November 5, 2025

    Report

    Report Number
    3005180920-2025-01063
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885037
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2025. STEM: M-VIZION 01.22.106 DISTAL STEM Ø17MM L 140MM STRAIGHT LOT. 2101129 (K170690): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JULY-2021. EXPIRATION DATE: 2026-07-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. STEM: M-VIZION 01.22.401 PROXIMAL BODY Ø20MM L 40MM STD WITH HOLES LOT. 2247722 (K170690) LOT 2247722: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MARCH-2023. EXPIRATION DATE: 2028-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, ALTHOUGH IT IS POSSIBLE THAT FACTORS SUCH AS LOW BONE QUALITY MAY HAVE CONTRIBUTED TO THE EVENT. ALTHOUGH NO ROOT CAUSE CAN BE CONFIRMED, THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491519 M-VIZION FEMORAL REVISION SYSTEM DISTAL STEM Ø17MM L 140MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.106 2101129 07630030885037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention