BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

    MDR report key: 11831978 · Received May 17, 2021

    Report

    Report Number
    3005180920-2021-00412
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971240834
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 APRIL 2021: LOT 1901214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2020. EXPIRATION DATE: 2025-01-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 30 APRIL 2021: STEM: M-VIZION 01.22.161 DISTAL STEM Ø12MM L 220MM STRAIGHT (K191816) LOT 1901248: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-11-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 3 MONTHS AFTER THE PRIMARY DUE TO SUBSIDENCE OF PROXIMAL AND DISTAL PART OF THE STEM. THE SURGEON SUCCESSFULLY REVISED THE PROXIMAL BODY, DISTAL STEM, OPTION HEAD, AND OPTION SLEEVE WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733585 STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD HIP REVISION CEMENTLESS MODULAR STEM LZO MEDACTA INTERNATIONAL SA 01.22.005 1901214 07630971240834

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention