BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OSTEONICS ULNAR COMPONENT

    MDR report key: 23401967 · Received October 28, 2025

    Report

    Report Number
    0002249697-2025-01224
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    November 25, 2024
    Report Date
    October 28, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE REVISION IN 2025. AS PER PSS IMPLANT REQUEST: REVISION RIGHT OSTEONICS ELBOW. ELBOW WAS REVISED IN 1999 (PI 4131641). A NEW HUMERAL COMPONENT WAS IMPLANTED. ULNAR STEM IS LOOSE. IT WILL BE CEMENTED INTO THE RADIUS. REQUIRE POLYS/AXLE AND CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353023 UNKNOWN OSTEONICS ULNAR COMPONENT PROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL KWJ STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| H