BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM

    MDR report key: 19084714 · Received April 10, 2024

    Report

    Report Number
    1038671-2024-00789
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 11, 2024
    Report Date
    September 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862079305
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. 4697961 320-15-05 - EQ REV LOCKING SCREW 4700324 320-38-03 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 4980155 320-15-04 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT 4994096 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM 5033192 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM 5036261 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM 5093116 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 5116438 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Additional Manufacturer Narrative · 0

    H3: THE GEOSPHERE, LINER AND ADAPTER TRAY WERE APPROPRIATELY RELEASED FOR DISTRIBUTION. THE REASON FOR THE PATIENT'S INFECTION AND SUBSEQUENT REVISION PROCEDURE AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED. THERE WAS NO MEDICAL OR CLINICAL INFORMATION PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS MANUFACTURER NARRATIVE UPDATED: THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE HUMERAL STEM AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) HUMERAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 82 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE REVISION WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE HUMERAL STEM. THE GLENOSPHERE WAS EXCHANGED FOR AN EXACTECH DEVICE. THE STEM WAS REMOVED AND REPLACED BY A COMPETITOR¿S PRODUCT. THERE WAS NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS ANTICIPATED AS THEY WERE DISCARDED BY THE HOSPITAL. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061961 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862079305

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention SEE H10