BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USP II HUMERAL HEAD 46/18

    MDR report key: 8006640 · Received October 25, 2018

    Report

    Report Number
    1220246-2018-00716
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057791
    PMA / PMN Number
    K071032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION OF HEMI TSA TO REVERS TSA PROCEDURE, THE KNOB ON THE SLAP HAMMER, AR-9202-14, BROKE OFF ON THE FOURTH ATTEMPT FOLLOWING THE EXTRACTION PROCEDURE STEPS. THE BROKEN PIECE WAS DISCARDED. THE SURGEON USED A BONE HOOK RETRACTOR (NON-ARTHREX) AND A SLOTTED MALLET, AR-9231-21, FROM THE BONE PREP TRAY TO COMPLETE THE EXTRACTION. THE INSTRUMENT BROKE CLEANLY INTO TWO PIECES. ADDITIONAL INFORMATION PROVIDED 9/19/2018: THIS WAS A REVISION FROM A HEMI ARTHROPLASTY WITH AN ARTHREX APEX STEM AND HARDWARE. NO GLENOID IMPLANTS. THE SURGERY WAS PERFORMED BECAUSE THE PATIENT FELL AND TORE HER ROTATOR CUFF A FEW MONTHS AGO. THE SURGEON FELT THAT A REVERSE TOTAL SHOULDER ARTHROPLASTY WOULD HAVE THE BEST OUTCOME FOR THE PATIENT. ZIMMER IMPLANTS WERE USED FOR THE REVERSE PROCEDURE. ADDITIONAL INFORMATION PROVIDED 10/2/2018: THE ORIGINAL DOS WAS (B)(6) 2017. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE ORIGINAL SURGERY AND EXPLANTED DURING THE REVISION: APEX HUMERAL STEM: AR-9100-10S/10128790. HUMERAL HEAD: AR-9146-18P/140107415.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844087 USP II HUMERAL HEAD 46/18 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. USP II HUMERAL HEAD 46/18 140107415 00888867057791

    Patients

    Seq Age Sex Outcome Treatment
    1 Other