BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 20396054 · Received October 8, 2024

    Report

    Report Number
    3005180920-2024-00794
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 9, 2024
    Report Date
    September 8, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263819
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-SEP-2024. LOT 2008351: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021. EXPIRATION DATE: 2026-04-06. 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 IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 16-SEP-2024. DM CONVERTER - TIN COATED (K211891) LOT 2012424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-06. 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. DOUBLE MOBILITY LINER (K092265) LOT 2344731: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2023. EXPIRATION DATE: 2028-12-03. 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. MECTACER BIOLOX DELTA FEMORAL BALL HEAD (K112115) LOT 2213111: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-08-23. 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.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION. THE SURGEON PERFORMED A DAIR AND REVISED SUCCESSFULLY THE M-VIZION PROXIMAL BODY, DM CONVERTER, DM LINER AND THE CERAMIC BALL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538767 M-VIZION FEMORAL REVISION SYSTEM STEM LZO MEDACTA INTERNATIONAL SA 01.22.448 2008351 07630971263819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention