BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT

    MDR report key: 20047955 · Received August 23, 2024

    Report

    Report Number
    1038671-2024-03027
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 3, 2024
    Report Date
    April 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    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): 320-06-38 - GLENOSPHERE 38MM: 7308798. 320-38-00 - 145-DEG PE 38MM HUM LINER +0: S383183. 300-30-10 - EQUINOXE PRESERVE STEM 10MM: A159595. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: A249664. 320-15-05 - EQ REV LOCKING SCREW: A240339. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: A220238. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: A027031. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: A186841. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM: 7287523. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM: S370014. 315-35-00 - GLND KWIRE: 6102820. 315-35-00 - GLND KWIRE: A185742.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF GLENOID LOOSENING. HOWEVER, THE REPORTED GLENOID LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    APPROXIMATELY 1 YEAR(S), 7 MONTH(S) AND 11 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING; GRADUAL INCREASE IN PAIN OVER LAST 6 MONTHS-LOOSE STILTED BASEPLATE SUPPORTED WITH MONTAGE. THE PATIENT UNDERWENT STANDARD REVERSE REVISION SURGERY AND WAS REVISED TO A SPACER. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363240 RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862186690

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female SEE H11.