BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM

    MDR report key: 20065570 · Received August 26, 2024

    Report

    Report Number
    1038671-2024-03071
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    April 1, 2022
    Report Date
    November 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862079305
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S: (B)(6). 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: (B)(6). 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA): (B)(6). 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS: (B)(6). 620-11-02 - ACCELERATE CONC. SYS REP BY 620-12-02: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G1, G3, H6 INVESTIGATION TYPE, FINDINGS, AND CONCLUSION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 COMPONENT CODE. THE REVISION REPORTED WAS LIKELY THE RESULT OF INSUFFICIENT BONDS BETWEEN THE IMPLANTS AND THE BONES, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. THE EXTENT AND ROOT CAUSE OF THE LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10 YEARS POST OP THE INITIAL TSA, THE PATIENT EXPERIENCED PROGRESSIVE HUMERAL LUCENCY ON X-RAY - NOW WITH GLENOID LOOSENING NOTED. NO SPECIFIC MOI NOTED. THE PATIENT UNDERWENT REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160258 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862079305

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female SEE H11.