BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESURFACING CAGE, 30MM

    MDR report key: 18065746 · Received November 3, 2023

    Report

    Report Number
    1038671-2023-02674
    Event Type
    Injury
    Date Received
    November 3, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 3, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862248572
    PMA / PMN Number
    K131298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 5240744 313-35-00 - 3MM X 250MM K-WIRE. 5284720 312-01-50 - RESURFACING HUMERAL HEAD 50MM.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2018. THE PATIENT PRESENTED ON (B)(6) 2023 AND NOT AE. PATIENT JUST HAS GLE GLENOID WEAR THE PATIENT WAS REVISED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, POSSIBLY RELATED TO PROCEDURE. OUTCOME: CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138570 RESURFACING CAGE, 30MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862248572

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention SEE H10.