BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA)

    MDR report key: 19704151 · Received July 9, 2024

    Report

    Report Number
    1038671-2024-02330
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862083937
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM: 7231165; 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S: 6895496; 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: 5558407; 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM: A123659; 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: A181542; 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS: 323221; 620-12-02 - ACCELERATE PRP 60 ML & ACD-A: A20220003; ASA0030 - STERILE DISPOSABLE CONTAINERS AB6695; TPA-18 - CEMENT RESTRICTOR SMALL AB8949; 13A2101 - CEMEX SYSTEM FAST GENTA 70G AB8333.

    Description of Event or Problem · 0

    APPROXIMATELY 1 YEAR(S), 6 MONTH(S) AND 27 DAY(S) POST-OPERATIVE OF A REVISED RIGHT TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. IT WAS DESCRIBED AS CONTINUED BONE LOSS OF THE GLENOID. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION SURGERY. THE OUTCOME OF THIS EVENT IS STILL CONSIDERED CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286649 EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA) PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862083937

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female