BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT

    MDR report key: 19217937 · Received April 30, 2024

    Report

    Report Number
    1038671-2024-01016
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    February 1, 2023
    Report Date
    August 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862186690
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-42-03 - 145-DEG PE 42MM HUM LINER +2.5 : A123998. 320-42-13 - 145-DEG PE 42MM CONST HUM LINER +2.5 : 5813501. 300-30-08 - EQUINOXE PRESERVE STEM 8MM : A266456. 320-06-42 - GLENOSPHERE 42MM : A196131. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 : A299979. 320-15-05 - EQ REV LOCKING SCREW : A281449. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT : A232424. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM : S397211. 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK : S386855. 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE : A063925. 315-35-00 - GLND KWIRE : A228734. 315-35-00 - GLND KWIRE : A228735. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM : A208986. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM : S387405. (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE POST OPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO IMPLANT POSITIONING, PATIENT BONE QUALITY, A TRAUMA, AND/OR ANOTHER PATIENT RELATED CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 76-YEAR-OLD NON-HISPANIC WHITE FEMALE HAD A RIGHT TSA ON (B)(6) 2022. THE PATIENT PRESENT WITH OTHER SCAPULAR FRACTURE ON (B)(6) 2023. THE PATIENT HAD TO USE HER RIGHT ARM FOR TRANSFER AFTER POSTOP ANKLE FRACTURE AND DEVELOPED A GLENOID (NON-DISPLACED). NO ACTION WAS TAKEN FOR THIS EVENT AND THE OUTCOME IS CONSIDERED RESOLVED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154208 RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862186690

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female SEE H10