BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD

    MDR report key: 19069664 · Received April 9, 2024

    Report

    Report Number
    3005180920-2024-00231
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971240841
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 APRIL 2024. LOT 2006782: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2021. EXPIRATION DATE: 2026-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BALL HEADS: COCR 01.25.124 COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5 (K080885) LOT 2215389: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2022. EXPIRATION DATE: 2027-09-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB (K131458) LOT 2239482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-NOV-2022. EXPIRATION DATE: 2027-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.32.3641CF DM CONVERTER TIN COATED D/DMB (K211891) LOT 2236984: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2023. EXPIRATION DATE: 2028-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AFTER THE PRIMARY, THE SURGEON REVISED THE PROXIMAL MVIZION BODY, DM CONVERTER, DM LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456416 STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD HIP FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 2006782 07630971240841

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention