BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USP II HUMERAL HEAD 46/20

    MDR report key: 8209297 · Received January 2, 2019

    Report

    Report Number
    1220246-2019-00829
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    May 1, 2017
    Report Date
    January 2, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057807
    PMA / PMN Number
    K071032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2017 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-9100-10S LOT: 10055062; AR-9106-01 LOT: 1027261611 AND AR-9146-20P LOT: 160051618. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION TSA/GLENOID REVISION AND HUMERAL HEAD SIZE REDUCTION FOR AN UNKNOWN REASON AND THE FOLLOWING DEVICES WERE EXPLANTED: AR-9106-01 LOT: 1027261611 AND AR-9146-20P LOT: 160051618. THESE WERE REPLACED WITH: AR-9105-01 LOT: 113601629 AND AR-9144-19P LOT: 160047318.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3583 USP II HUMERAL HEAD 46/20 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. USP II HUMERAL HEAD 46/20 160051618 00888867057807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other