BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 20743052 · Received November 21, 2024

    Report

    Report Number
    3005180920-2024-00982
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263680
    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 6 NOVEMBER 2024: LOT 2101198: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2022. EXPIRATION DATE: 2026-DEC-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW (THE OTHER EVENT HAPPENED WITH THE SAME PATIENT). ADDITIONAL IMPLANT REVISED, BATCH REVIEW PERFORMED ON 6 NOVEMBER 2024: STEM: M-VIZION 01.22.103 DISTAL STEM Ø14MM L 140MM STRAIGHT (K170690) LOT 2318726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2024. EXPIRATION DATE: 2029-JAN-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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE PROXIMAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE PROXIMAL BODY AND DISTAL STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE OTHER COMPONENTS ARE COMPETITORS. THE SURGEON THINKS ALL COMPONENTS SHOULD BE REMOVED/REVISED FOR THE WASHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430278 M-VIZION FEMORAL REVISION SYSTEM PROXIMAL BODY Ø24MM L 40MM LAT WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.427 2101198 07630971263680

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention