BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL

    MDR report key: 23402522 · Received October 28, 2025

    Report

    Report Number
    0002249697-2025-01237
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    May 9, 2025
    Report Date
    October 28, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST: FAILED R TOTAL ELBOW ARTHROPLASTY FROM 1991. PATIENT HAS AN IMPLANTED TOTAL ELBOW PROSTHESIS, THOUGHT TO BE THE OLD OSTEONICS IMPLANT. THE HUMERAL AND ULNAR COMPONENTS APPEAR WELL-FIXED. HOWEVER, THE LINK BETWEEN THE TWO IS BROKEN. PLAN IS TO MAINTAIN THE HUMERAL AND ULNAR COMPONENTS AND TO REVISE THE POLY BUSHINGS AS WELL AS THE LINKAGE PIN. SINCE THE IMPLANTS ARE NO LONGER MANUFACTURED, PLEASE HELP WITH CUSTOM BUILD OF THESE PARTS OF THE PROSTHETIC. WOULD LIKE TO RETAIN THE WELL-FIXED IMPLANTS AND ONLY REPLACE THE WORN OUT / BROKEN PARTS. IF WE CAN'T USE THE CUSTOM DEVICE, THEN WE WOULD HAVE TO REMOVE THE ULNAR AND HUMERAL STEMS, WHICH COULD BE QUITE DESTRUCTIVE FOR THE BONE AROUND THE IMPLANTS AND MAY MAKE REIMPLANTATION OF ANOTHER PROSTHETIC DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428377 UNKNOWN PROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL PROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL KWJ STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization| R