BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 20724173 · Received November 19, 2024

    Report

    Report Number
    3005180920-2024-00952
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030884993
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 OCTOBER 2024: LOT 2336074: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2024. EXPIRATION DATE: 2029-01-10. 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: BATCH REVIEW PERFORMED ON 28 OCTOBER 2024: STEM: M-VIZION 01.22.402 PROXIMAL BODY Ø20MM L 50MM STD WITH HOLES (K201471) LOT 2312600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 2028-10-24. 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. CONCLUSIONS: THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING WHICH CAUSED A PERIPROSTHETIC FRACTURE. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON THINKS THAT THE STEM WAS UNDERSIZED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144593 M-VIZION FEMORAL REVISION SYSTEM DISTAL STEM Ø13MM LZO MEDACTA INTERNATIONAL SA 01.22.102 2336074 07630030884993

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention