BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS II HUMERAL HEAD 56/22

    MDR report key: 20854169 · Received December 5, 2024

    Report

    Report Number
    1220246-2024-08711
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 4, 2024
    Report Date
    August 22, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867136595
    PMA / PMN Number
    K071032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON VISUAL INSPECTION AND ANALYSIS THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON 11/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A SHOULDER SCOPE ARTHROPLASTY PROCEDURE COMPLETED SUCCESSFULLY THREE YEARS AGO. THE PATIENT REPORTED HAVING POST-SURGERY ADVERSE REACTIONS TO THE IMPLANT THAT WAS IMPLANTED. THE SURGEON PERFORMED A BIOPSY AND FOUND METALLOSIS IN THE JOINT. PHOTOS WERE TAKEN OF THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/08/2024 VIA EMAIL: ON 11/04/2024, THE SURGEON BROUGHT ONE OF HIS PATIENTS BACK TO THE OPERATING ROOM FOR A BIOPSY AND DIAGNOSTIC ARTHROPLASTY TO SEE WHY, AFTER A SUCCESSFUL TSA OUTCOME, THE PATIENT HAD SUDDENLY EXPERIENCED A HIGH AMOUNT OF PAIN IN THE LAST 6 MONTHS. SHOTS AND CONSERVATIVE TREATMENTS FAILED, AND THE PATIENT WAS BROUGHT INTO THE OR FOR ARTHROSCOPIC EVALUATION. THE SURGEON FOUND SEVERE METALLOSIS IN THE JOINT (PHOTO ATTACHED). NO FAILURE OF IMPLANTS OR LOOSENESS COULD NOT BE DETERMINED AT THE TIME. THE SURGEON TOOK THE ARTHROSCOPIC BIOLOGICAL CULTURES AND SENT THEM TO THE LAB FOR ANALYSIS. THE ARTHREX PRODUCTS IMPLANTED IN THE INITIAL SURGERY WERE AR-9106-03 ARTHREX UNIVERS VAULTLOCK GLENOID, AR-9100-11S UNIVERS APEX HUMERAL STEM, AND AR-9156-22P ARTHREX UNIVERS II 3D HUMERAL HEAD. THE INITIAL SURGERY WAS DONE ON 11/14/2021 AT THE SAME LOCATION AS THE DIAGNOSTIC SCOPE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 11/22/2024 VIA EMAIL: THE REACTION WAS LOCALIZED IN THE SHOULDER JOINT, AND NO REVISION HAS BEEN SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051988 UNIVERS II HUMERAL HEAD 56/22 PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. UNIVERS II HUMERAL HEAD 56/22 10525390 00888867136595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other