BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT

    MDR report key: 12560085 · Received October 1, 2021

    Report

    Report Number
    3005180920-2021-00785
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 2, 2021
    Report Date
    October 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030884993
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2021: LOT 2007036: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-02-2021. EXPIRATION DATE: 2026-01-21 NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2021: STEM: M-VIZION 01.22.008 PROXIMAL BODY Ø20MM L 50MM LAT (K170690) LOT 186406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-12-2019. EXPIRATION DATE: 2024-11-23 NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L (K112115) LOT 2011682: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-03-2021. EXPIRATION DATE: 2026-02-21. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459049 STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT DISTAL STEM LZO MEDACTA INTERNATIONAL SA 01.22.102 2007036 07630030884993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention