BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, SMALL

    MDR report key: 19931896 · Received August 7, 2024

    Report

    Report Number
    1220246-2024-07079
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    October 6, 2023
    Report Date
    December 26, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057319
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INITIAL ECLIPSE SURGERY IN (B)(6) 2014 A REVISION SURGERY OF THE SMALL PEGGED GLENOID WAS NECESSARY IN (B)(6) 2023 DUE TO A GLENOID LOOSENING. NO FURTHER INFORMATION RECEIVED. ***UPDATE DW 05-AUG-2024: FURTHER INFORMATION WERE PROVIDED THAT AN AR-9105-01 WITH THE LOT 1419021 WAS IMPLANTED ON (B)(6) 2014 AND THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534767 GLENOID, PE WITH PEG, SMALL PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. GLENOID, PE WITH PEG, SMALL 1419021 00888867057319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other