BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID L, POST AUG, LEFT

    MDR report key: 18465133 · Received January 8, 2024

    Report

    Report Number
    1038671-2024-00031
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    November 12, 2019
    Report Date
    January 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862200983
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 300-30-06 - EQUINOXE PRESERVE STEM 6MM: 4963983 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA): 5044142 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S: 5082308.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2017 AND PRESENTED ON 12-NOV-2019 WITH ASEPTIC GLENOID LOOSENING. GLENOID LOOSENING AND HUMERAL BONE LOSS. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. OUTCOME IS RESOLVED BY REVISION ON 18-DEC-2019. SPACER - HUGE BONE LOSS. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY. EBI INITIAL SURGERY ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950072 EQUINOXE CAGE GLENOID L, POST AUG, LEFT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK 10885862200983

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male SEE H10