BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS GLENOID PLATE EXT CAG +10MM CAGE PEG

    MDR report key: 17338554 · Received July 17, 2023

    Report

    Report Number
    1038671-2023-01684
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    June 14, 2023
    Report Date
    May 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862186706
    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

    CONCOMITANT MEDICAL PRODUCTS:REVERSE GLENOSPHERE 3200242.HUMERAL STEM OR STEMLESS 3000115.REVERSE HUMERAL LINER 3204200.REVERSE HUMERAL TRAY 3201000.

    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 AN INSUFFICIENT BOND BETWEEN THE GLENOID COMPONENT AND THE BONE INTERFACE, WHICH LED TO ASEPTIC LOOSENING. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE 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

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 43 YO MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE DATE OF EVENT ONSET IS (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2023. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616265 RS GLENOID PLATE EXT CAG +10MM CAGE PEG PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK UNK 10885862186706

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other| R SEE H10.