BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 23197949 · Received October 2, 2025

    Report

    Report Number
    3005180920-2025-00921
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 22, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-09-2025. STEM: M-VIZION 01.22.103 DISTAL STEM Ø14MM L 140MM STRAIGHT (K170690) LOT. 2241930: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-01-2022. EXPIRATION DATE: 2026-12-15. 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 COMPONENT INVOLVED AND REVISED: STEM: M-VIZION 01.22.411 PROXIMAL BODY Ø20MM L 80MM LAT WITH HOLES (K201471) LOT. 2010784: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-01-2023. EXPIRATION DATE: 2027-12-19. 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. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278337 M-VIZION FEMORAL REVISION SYSTEM DISTAL STEM Ø14MM LZO MEDACTA INTERNATIONAL SA 01.22.103 2241930

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention