BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION DISTAL STEM Ø14MM L 180MM STRAIGHT

    MDR report key: 17489189 · Received August 9, 2023

    Report

    Report Number
    3005180920-2023-00644
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 9, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040728911
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02-AUG-2023: LOT 1901233: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2019. EXPIRATION DATE: 2024-10-23. 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 INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 02-AUG-2023 ON STEM: M-VIZION 01.22.403 PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES (K201471) LOT. 2010776. LOT 2010776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEPT-2021. EXPIRATION DATE: 2026-09-15. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR DUE TO FALLING. THE SURGEON REVISED THE STEM, HEAD AND LINER AND CABLED THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE STEM AND PERFORMED A GIRDLESTONE HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892460 STEM: M-VIZION DISTAL STEM Ø14MM L 180MM STRAIGHT HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1901233 07630040728911

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention