BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

    MDR report key: 15258829 · Received August 19, 2022

    Report

    Report Number
    3005180920-2022-00628
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 22, 2022
    Report Date
    August 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263529
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 AUGUST 2022: LOT 2007094: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-APR-21. 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 IMPLANTED COMPONENT. BATCH REVIEW PERFORMED ON 19 AUGUST 2022 ON STEM: M-VIZION 01.22.139 DISTAL STEM Ø20MM L 180MM STRAIGHT (K191816) LOT. 1901239. LOT 1901239: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2019. EXPIRATION DATE: 2026-APR-21. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PROXIMAL BODY, HEAD, AND LINER 5 MONTHS AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847217 STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES HIP STEM WITH STD WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.403 2007094 07630971263529

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention