BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS APEX HUMERAL STEM, 10MM

    MDR report key: 14601955 · Received June 6, 2022

    Report

    Report Number
    1220246-2022-05022
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 10, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867134607
    PMA / PMN Number
    K131633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNABLE TO BE CONFIRMED BASED ON THE CUSTOMER-PROVIDED PHOTOS, WHICH DO NOT DISPLAY THE ALLEGED INFECTION OR REVISION. NO CHANGE IN HARM WAS IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2020 . IN (B)(6) 2021, PATIENT COMPLAINED OF PAIN. ON (B)(6) 2022, PATIENT WAS POSITIVE FOR A C. ACNES INFECTION AND UNDERWENT REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION ARTHROPLASTY SURGERY, AN AR-9106-02 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9100-10S UNIVERS APEX HUMERAL STEM, AND AN AR-9148-19P ARTHREX UNIVERS II 3D HUMERAL HEAD WERE EXPLANTED. CASE WAS COMPLETED BY IMPLANTING AN ANTIBIOTIC CEMENT SPACER. THE ORIGINAL SHOULDER ARTHROPLASTY PROCEDURE, WAS PERFORMED AT FOX VALLEY ORTHOPEDIC ASSOCIATES SURGERY CENTER BY A DIFFERENT SURGEON. ADDITIONAL INFORMATION RECEIVED ON 5/18/2022: ALL DEVICES THAT WERE IMPLANTED ON (B)(6) 2020 WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2022. AFTER PATIENT COMPLAINT OF PAIN IN (B)(6) OF 2021, PATIENT WAS MONITORED AND REVISION SURGERY WAS SCHEDULE. DUE TO OTHER NON-ORTHOPEDIC REASONS, REVISION SURGERY WAS DELAYED UNTIL (B)(6) 2022. OTHER THAN THE ANTIBIOTIC CEMENT SPACER, NO NEW ARTHREX DEVICES WERE IMPLANTED DURING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305306 UNIVERS APEX HUMERAL STEM, 10MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 10MM 10407310 00888867134607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other