BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS VAULTLOCK GLENOID, SMALL

    MDR report key: 7902547 · Received September 24, 2018

    Report

    Report Number
    1220246-2018-00666
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 24, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867239319
    PMA / PMN Number
    K161108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 ON (B)(6) 2017, THE PATIENT UNDERWENT A REVERSE TSA PROCEDURE WHERE A UNIVERSAL APEX HUMERAL STEM, AR-9100-07S, LOT: 10127600; A USPII HUMERAL HEAD, AR-9146-20P, LOT: 250133268; AND A UNIVERSAL VAULTLOCK GLENOID, AR-9106-01, LOT: 1012679, WERE IMPLANTED. IN (B)(6) OF 2018, ABOUT 6 MONTHS POST-OP, THE PATIENT WAS COMPLAINING THAT HIS SHOULDER FELT LOOSE. AN X-RAY WAS TAKEN AND THE SURGEON DETERMINED THAT THE GLENOID HAD FAILED AND A REVISION SURGERY WOULD BE NEEDED. ON (B)(6) 2018, A REVISION RTSA PROCEDURE WAS PERFORMED WHERE ALL THREE OF THE IMPLANTED DEVICES WERE EXPLANTED AND REPLACED WITH AN ARTHREX RTSA SYSTEM. THE EXPLANTED HARDWARE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745304 UNIVERS VAULTLOCK GLENOID, SMALL PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, SMALL 10126791 00888867239319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other