BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS APEX HUMERAL STEM, 10MM

    MDR report key: 8006632 · Received October 25, 2018

    Report

    Report Number
    1220246-2018-00715
    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
    00888867134607
    PMA / PMN Number
    K131633
    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. THE 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
    843886 UNIVERS APEX HUMERAL STEM, 10MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 10MM 10128790 00888867134607

    Patients

    Seq Age Sex Outcome Treatment
    1 Other