BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE GLENOSPHERE 38MM

    MDR report key: 20822738 · Received December 2, 2024

    Report

    Report Number
    1038671-2024-04565
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    September 30, 2021
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862563699
    PMA / PMN Number
    K193098
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. CONCOMITANTS: 320-38-00 145-DEG PE 38MM HUM LINER +0 (B)(6). A10012 - GPS IMPLANT KIT V2 (B)(6). EXC-EQRV38-US - ORTHOSENSOR 38MM USA (B)(6). 300-30-10 - EQUINOXE PRESERVE STEM 10MM (B)(6). 320-15-02 - RS GLENOID PLATE SUP (B)(6) DEG (B)(6). 531-20-00 - SHLDR GPS RVRS DRILL KIT (B)(6). 531-78-20 - SHOULDR GPS HEX PINS KIT (B)(6). 320-15-05 - EQ REV LOCKING SCREW (B)(6). 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT (B)(6). 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM (B)(6). 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM (B)(6). 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM (B)(6). 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 MONTH POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT UNDERWENT REVISION OF THE PROSTHESIS DUE TO DISLOCATION. THE PATIENT WAS WHEELCHAIR-BOUND AND WITHIN THE FIRST COUPLE WEEKS AFTER IMPLANT, REACHED OVER A CHAIR AND DISLOCATED THE PROSTHESIS. THE SURGEON PROCEEDED TO REVISE THE PATIENT TO LARGER AND CONSTRAINED IMPLANTS. THE GLENOSPHERE, LOCKING SCREW, AND LINER WERE SWAPPED OUT. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THERE WAS A SURGICAL DELAY/PROLONGATION OF APPROXIMATELY 30-45 MINUTES IN RELATION TO THE NEED FOR REVISION SURGERY DUE TO THE DISLOCATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95057 EQUINOXE GLENOSPHERE 38MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862563699

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention SEE H11.