BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 24913767 · Received April 17, 2026

    Report

    Report Number
    3004976965-2026-00007
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 14, 2026
    Report Date
    May 15, 2026
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096401394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, ZIMMER BIOMET. COMPLAINT SOURCE IS FOREIGN AS EVENT OCCURRED IN CANADA.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT WHILE REAMING THE ACETABULUM THE REAMER SHAFT WASN'T STABLE AND WAS WOBBLING. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69040 VIANT MEDICAL, LLC EZ CLEAN¿ REAMER HANDLE LXH VIANT MEDICAL, LLC T2756 5621158 00840096401394

    Patients

    Seq Age Sex Outcome Treatment
    1