BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHMWPE POST AUG GLENOID MEDIUM, RIGHT

    MDR report key: 21138025 · Received January 13, 2025

    Report

    Report Number
    1038671-2025-00204
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 16, 2024
    Report Date
    May 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862175106
    PMA / PMN Number
    K103419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H3: THE REVISION REPORTED WAS LIKELY DUE TO PROTHESIS WEAR, LOOSENING, AND SUBSEQUENT MIGRATION. THE CAUSE OF THE WEAR, LOOSENING AND MIGRATION CANNOT BE CONFIRMED BUT MAY BE DUE TO UNDERLYING ROTATOR CUFF DEFICIENCIES LEADING TO SUPERIOR MIGRATION OF THE HUMERAL HEAD, THE HUMERAL BONE IMPINGING ON THE IMPLANT CREATING A ROCKING HORSE MOTION AROUND A WELL-FIXED CAGE, SURGICAL TOOL DAMAGE, AND/OR THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 312-01-47 - RESURFACING HUMERAL HEAD 47MM 4160068 312-01-01 - RESURFACING CAGE, 25MM 4781745 H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. THE PATIENT HAD A HUMERAL RESURFACING AND OVER TIME THE GLENOID COMPONENT FAILED. THE SURGEON CARRIED OUT A 1ST STAGE REVISION WITH THE INTENT TO DO A 2ND STAGE INSERTING AN EXACTECH REVERSE SHOULDER. THE PATIENT HAS A CEMENT SPACER INSITU AND IS AWAITING A 2ND STAGE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498643 UHMWPE POST AUG GLENOID MEDIUM, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862175106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11