BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT

    MDR report key: 15571392 · Received October 10, 2022

    Report

    Report Number
    1038671-2022-01280
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    September 12, 2022
    Report Date
    November 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862534897
    PMA / PMN Number
    K180632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURNING AS THE HOSPITAL DISPOSED OF IT. CONCOMITANTS: 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM 7311586, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 7316700, 320-15-05 - EQ REV LOCKING SCREW 7312244, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 7294616, 320-35-04 - SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT 7033769, 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED 7223562, BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR ACROMIAL STRESS FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO PATIENT CONDITION AND THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OVER 75 YO FEMALE PATIENT, WHO HAD AN INITIAL SHOULDER PROCEDURE ON (B)(6) 2022, SUFFERED AN ACROMIAL STRESS FRACTURE. THE SURGEON EXCHANGED THE GLENOSPHERE, GLENOSPHERE LOCKING SCREW, HUMERAL TRAY, TORQUE SCREW AND HUMERAL LINER TO DETENTION THE PATIENT. THE PATIENT HAD 25 DEGREES OF GLENOID RETROVERSION. THE SURGEON USED AN AUGMENTED BASE PLATE AND EXPANDED GLENOSPHERE TO CORRECT VERSION AND MAINTAIN JOINT TENSION. IN HINDSIGHT HE REGRETS LATERALIZING HER WITH THE EXPANDED OPTION AND THINKS HE MAY HAVE OVER TENSIONED HER LEADING TO THE ACROMIAL FRACTURE .THERE WAS NO DIRECT TRAUMA TO THE SHOULDER. THE PATIENT HAD A LOW BMI AND WAS RELATIVELY HEALTHY CONSIDERING HER AGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800293 SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER KWS EXACTECH, INC. EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE UNK 10885862534897

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention