BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, SMALL

    MDR report key: 9910320 · Received April 1, 2020

    Report

    Report Number
    1220246-2020-01771
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 3, 2020
    Report Date
    August 19, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057319
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE GLENOID AR-9105-01 WAS RETURNED HEAVILY DAMAGED AND WITH BROKEN PEGS AND KEEL. THE CAUSE IS UNDETERMINED.

    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 ROOT 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 A REVISION SHOULDER SURGERY WAS PERFORMED DUE TO A GLENOID COMPONENT ABRASION/ LOOSENING ON THE RIGHT. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2014. THE PROSTHESES WAS REPLACED WITH AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377494 GLENOID, PE WITH PEG, SMALL PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. GLENOID, PE WITH PEG, SMALL 1227014 00888867057319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other