BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL LINER +0

    MDR report key: 19084412 · Received April 10, 2024

    Report

    Report Number
    1038671-2024-00786
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 12, 2024
    Report Date
    September 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 7121172 - 300-30-08 - EQUINOXE PRESERVE STEM 8MM A646028 - 315-35-00 - GLND KWIRE A595312 - 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE A611123 - 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5 A600541 - 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG A608993 - 320-15-05 - EQ REV LOCKING SCREW A534545 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A569345 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S4577030 - 20-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S456165 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM A557634 - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM A613320 - 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0 A482013 - 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE A587779 - 531-78-20 - SHOULDR GPS HEX PINS KIT A588407 - 531-78-20 - SHOULDR GPS HEX PINS KIT 2016823125 - A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF INFECTION. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THE HUMERAL STEM SUBSIDENCE MAY HAVE BEEN THE RESULT OF INSUFFICIENT BONY SUPPORT FOR THE IMPLANT, PATIENT-RELATED CONDITIONS, IMPROPER BONE PREPARATION DURING THE INITIAL SURGERY, OR A COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    AS REPORTED, THE 62 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TSA ON 09-JAN-2023. THE PATIENT WAS EXPERIENCING LOW GRADE DISCOMFORT AND PAIN. THE AREA WAS RED, SWOLLEN AND HOT FOR SOME TIME. HE PRESENTED TO ED A FEW MONTHS AGO AND THERE WAS SUSPICION OF INFECTION WITH SOME PUSS REMOVED. DURING REVISION SURGERY ON (B)(6) 2024, IT WAS NOTED THAT A VERY HIGH NUMBER OF ANCHORS AND SUTURES WERE PRESENT. THIS MAY HAVE CONFOUNDED THE REVISION DUE TO INFECTION. THE IMPLANTS REMOVED SHOWED PRESENCE OF MILD INFECTION. SPECIMENS WERE TAKEN AND SENT TO PATHOLOGY. THE PRESERVE STEM WITH +5MM TRAY HAD SUBSIDED AND THE HUMERUS NEEDED TO BE RESECTED. THERE WAS SO MUCH SCARRING AND THE DISCUSSION WAS THE SURGEON DIDN'T WANT FURTHER SUBSIDENCE, SO A +0MM TRAY WAS SELECTED. THE HUMERAL LINER, TRAY AND SCREW WERE REVISED. THE GLENOSPHERE, LOCKING SCREW AND 4 SCREWS FROM THE BASEPLATE (NO LOCKING CAPS WERE PRESENT) WERE ALSO REVISED. THE SITE WAS DEBRIDED, WASHED OUT, AND IMPLANTS REPLACED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR 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
    1893176 EQUINOXE REVERSE 42MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

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