BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 21503345 · Received March 3, 2025

    Report

    Report Number
    3005180920-2025-00146
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    February 8, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885006
    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 14-02-2025: LOT 2101126: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-07-2021. EXPIRATION DATE: 2026-07-12. 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 DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 14-FEBRUARY-2025: M-VIZION 01.22.422 PROXIMAL BODY Ø24MM L 50MM STD WITH HOLES (K201471) LOT 2010787: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-01-2022. EXPIRATION DATE: 2026-12-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MECTACER 01.29.210 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L (K112115) LOT 2422261: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-09-2024. EXPIRATION DATE: 2029-08-20. 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. MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2406333: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-04-2024. EXPIRATION DATE: 2029-03-21. 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. MPACT 3D METAL 01.38.358MH MPACT 3D METAL SHELL MULTI HOLE THIN Ø58MM (K202568) LOT 2338689: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-12-2023. EXPIRATION DATE: 2028-11-28. 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

    AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330640 M-VIZION FEMORAL REVISION SYSTEM STEM: M-VIZION DISTAL STEM Ø14MM L 140MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.103 2101126 07630030885006

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention