BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER COMPONENTS

    MDR report key: 19122324 · Received April 16, 2024

    Report

    Report Number
    1038671-2024-00876
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    January 17, 2024
    Report Date
    October 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 3777348 - 320-10-15 - HUMERAL TRAY +15MM 6580730 - 320-08-38 - GLENOSPHERE EXP 38MM +4MM OFFSET 6822073 - 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM 6943150 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT (B)6)- 320-15-05 - EQ REV LOCKING SCREW S244095 - 320-38-00 - 145-DEG PE 38MM HUM LINER +0.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. EXPIRATION AND MANUFACTURED DATES ARE UNKNOWN. THE CAUSE OF THE SCREW FRACTURE AND LOSS OF RANGE OF MOTION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, POSSIBLE ROOT CAUSES INCLUDE IMPROPER SEATING OF THE GLENOID BASEPLATE, TRAUMA, INSUFFICIENT BONE QUALITY BEHIND THE GLENOID BASEPLATE, AND/OR POSSIBLE PATIENT-RELATED RISK FACTORS. THIS CANNOT BE CONFIRMED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A VOLUNTARY MEDWATCH REPORT #MW5152512 , THAT A MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2021, WHO UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021, UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 2 YEARS 7 MONTHS POST THE FIRST REVISION PROCEDURE. FOLLOWING THE INITIAL IMPLANT PROCEDURE, THE REPORTER CALLED TO REPORT PROBLEMS AFTER HER HUSBAND RECEIVED 2 EQUINOXE SHOULDER SYSTEM REPLACEMENTS, EACH FOR THE LEFT SHOULDER. THE REPORTER STATES HER HUSBAND HAD INITIAL SHOULDER REPLACEMENT SURGERY ON (B)(6) 2021, AND CAME DOWN WITH AN INFECTION ALMOST IMMEDIATELY AFTER IMPLANT, CONFIRMED BY A CT SCAN. ALL SHOULDER COMPONENTS WERE REMOVED EXCEPT FOR THE SHOULDER BALL, AND THE SHOULDER SITE WAS THOROUGHLY WASHED OUT BEFORE A NEW EQUINOXE DEVICE WAS AGAIN IMPLANTED ON (B)(6) 2021. SHE STATES HER HUSBAND WAS PRESCRIBED DOXYCYCLINE AT THAT TIME AND CONTINUES WITH THAT PRESCRIPTION TODAY. THE REPORTER STATES THAT AFTER THIS REPLACEMENT SURGERY, HER HUSBAND CONTINUED TO EXPERIENCE PAIN AND LIMITED RANGE OF MOTION IN THE LEFT SHOULDER. SHE STATED THAT ON AN UNKNOWN DATE IN 2024, X-RAYS SHOWED BROKEN SCREWS IN THE EQUINOXE SHOULDER SYSTEM AND AN EXPLANT PROCEDURE WAS ONCE AGAIN PERFORMED. THEY STATED THAT ON AN UNKNOWN DATE IN 2024, THE SURGICAL INCISION SITE DEVELOPED A HEMATOMA AND REQUIRED MEDICAL ATTENTION. SHE STATED THAT IN JANUARY 2024, SHE RECEIVED A NOTIFICATION ON HER CELL PHONE THAT THE EQUINOXE SHOULDER SYSTEM WAS ¿UNDER A FDA RECALL¿ AND LEARNED HER HUSBAND¿S TWO EQUINOXE SHOULDER SYTEMS WERE PART OF THE RECALL. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063101 UNKNOWN SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male UNK.