BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 25194480 · Received May 15, 2026

    Report

    Report Number
    3004976965-2026-00009
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 21, 2026
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096401394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, ZIMMER BIOMET. COMPLAINT SOURCE IS FOREIGN AS EVENT OCCURRED IN CANADA. H3: THE CUSTOMER HAS INDICATED THE COMPLAINT SAMPLE WILL BE RETURNED TO VIANT FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED TO DATE. ONCE THE COMPLAINT SAMPLE IS RECEIVED, IT WILL BE INVESTIGATED AND A FOLLOW-UP MEDWATCH 3500A EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THE REAMER WOBBLES WHEN REAMING THE ACETABULUM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197665 VIANT MEDICAL, LLC EZ CLEAN¿ REAMER HANDLE LXH VIANT MEDICAL, LLC T2756 5548636 00840096401394

    Patients

    Seq Age Sex Outcome Treatment
    1