BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

    MDR report key: 17642845 · Received August 29, 2023

    Report

    Report Number
    1038671-2023-02076
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    July 25, 2023
    Report Date
    December 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086709
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): HUMERAL ADAPTOR TRAY +0MM 320-10-00 5900857. GLENOSPHERE 42MM 320-01-42 6154427. HUMERAL LINER 42MM, +2.5MM 320-42-03 4483543. GLENOSPHERE LOCKING SCREW 320-15-05 6113795. REVERSE SHOULDER TORQUE DEFINING SCREW 320-20-00 6115379. RS GLENOID PLATE SUP AUG, 10 DEG 320-15-02 5958989. EQUINOXE PRESERVE STEM 11MM 300-30-11 5729693. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 5930239. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 6113880. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 320-20-26 6015034. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 320-20-42 6058870.

    Additional Manufacturer Narrative · 0

    SECTION H10: (G2) REPORT SOURCE - COMPANY REPRESENTATIVE SHOULD HAVE BEEN CHECKED (G4) DATE RECEIVED BY MANUFACTURER ¿ DATE ON FINAL SUBMISSION SHOULD HAVE BEEN (B)(6) 2023 (G6) TYPE OF REPORT - 30-DAY SHOULD HAVE BEEN CHECKED ALONG WITH FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    SECTION H10: H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF INCOMPLETE SEATING OF THE LINER DURING IMPLANTATION, BONE IMPINGEMENT, PATIENT-RELATED CONDITIONS, AN UNREPORTED POST-TRAUMATIC EVENT, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO HUMERAL LINER DISASSOCIATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: H6: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: H6: COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT TSA, THIS 71 Y/O MALE PATIENT WAS REVISED DUE TO HUMERAL LINER DISSOCIATION. HUMERAL LINER WAS DISSOCIATED FROM THE HUMERAL TRAY. GLENOSPHERE, LINER AND TRAY WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTO ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185565 EQUINOXE REVERSE 42MM HUMERAL LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086709

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male SEE H10.