BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FX SOLUTION

    MDR report key: 24793125 · Received April 6, 2026

    Report

    Report Number
    0001649390-2026-00327
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    January 22, 2026
    Report Date
    April 6, 2026
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    A REVISION SURGERY, HOWEVER, THE REASON FOR THE REVISION IS STILL UNKNOWN. THE PATIENT HAD AN FX SOLUTION ORIGINALLY IMPLANTED, AND THIS WAS CONVERTED TO A PERFORM GLENOID AND HUMERAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400398 FX SOLUTION PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention