BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID L, POST AUG, LEFT

    MDR report key: 21785398 · Received April 7, 2025

    Report

    Report Number
    1038671-2025-01743
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    September 30, 2024
    Report Date
    July 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. D10: 05000821215, A10012 - GPS IMPLANT KIT V2. 6867468, 300-60-03 - STEMLESS HUMERAL COMP LASER CAGE, SIZE 3. 7220219, 310-62-47 - STEMLESS HUMERAL HEAD 47MM X 15MM X BETA. 7314948, 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM. A132641, 531-78-20 - SHOULDR GPS HEX PINS KIT. A132650, 531-78-20 - SHOULDR GPS HEX PINS KIT.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN DUE TO LOOSENING AND INFECTION AS REPORTED. SECONDARY FINDINGS INCLUDE PROSTHESIS WEAR AND FRACTURE OF THE GLENOID COMPONENT, LIKELY DUE TO PROXIMAL MIGRATION OF THE HUMERAL COMPONENTS RELATIVE TO THE GLENOID AND/OR OFF-AXIS DRILLING OF THE PERIPHERAL PEGS HOLES RESULTING IN A ROCKING HORSE EFFECT AROUND A WELL-FIXED CAGE. HOWEVER, LOOSENING, INFECTION, AND THE SERIES OF EVENTS COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND INITIAL POST-OPERATIVE RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO LOOSENING. THE COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. PHOTOS PROVIDED SHOW WEAR AND FRACTURE OF THE GLENOID COMPONENT. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614516 EQUINOXE CAGE GLENOID L, POST AUG, LEFT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization SEE H11.