BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS GLENOID PLATE EXT CAG +10MM CAGE PEG

    MDR report key: 16291027 · Received February 3, 2023

    Report

    Report Number
    1038671-2023-00095
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    January 1, 2023
    Report Date
    May 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862186706
    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) THE GLENOID BASEPLATE LOOSENING REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE GLENOID BASEPLATE AND THE BONE AND/OR PATIENT-RELATED CONDITIONS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES AND RADIOGRAPHS WERE NOT AVAILABLE FOR EVALUATION. THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED BY THE EQUINOXE SHOULDER STUDY, THAT THIS 55 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. AT 2-YEAR FOLLOW-UP VISIT X-RAYS REVEALED GLENOID LOOSENING; HOWEVER, PATIENT REPORTS NO PAIN IN RIGHT SHOULDER. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. NO ACTION TAKEN, OUTCOME IS CONTINUING. (D1) BRAND NAME: RS GLENOID PLATE EXT CAG +10MM CAGE PEG, PRODUCT CODE: KWT, COMMON DEVICE NAME: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED (D4) CATALOG NUMBER: 320-15-06, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D10) CONCOMITANT DEVICE(S): 300-01-14 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM. 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-06-38 - GLENOSPHERE 38MM.

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION : CONCOMITANT MEDICAL PRODUCTS : 300-01-14 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM; 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0; 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 320-15-06 - RS GLENOID PLATE EXT CAG +10MM CAGE PEG.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE EQUINOXE SHOULDER STUDY, THAT THIS 55 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. AT 2-YEAR FOLLOW-UP VISIT X-RAYS REVEALED GLENOID LOOSENING; HOWEVER, PATIENT REPORTS NO PAIN IN RIGHT SHOULDER. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. NO ACTION TAKEN, OUTCOME IS CONTINUING.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE EQUINOXE SHOULDER STUDY, THAT THIS 55 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. AT 2-YEAR FOLLOW-UP VISIT X-RAYS REVEALED GLENOID LOOSENING; HOWEVER, PATIENT REPORTS NO PAIN IN RIGHT SHOULDER. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. NO ACTION TAKEN, OUTCOME IS CONTINUING. 320-15-06 - RS GLENOID PLATE EXT CAG +10MM CAGE PEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433184 RS GLENOID PLATE EXT CAG +10MM CAGE PEG PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862186706

    Patients

    Seq Age Sex Outcome Treatment
    1