BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE, RIGHT 16 POST AUG UHMWPE GLENOID

    MDR report key: 21922985 · Received April 28, 2025

    Report

    Report Number
    1038671-2025-01917
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    April 9, 2025
    Report Date
    September 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862228369
    PMA / PMN Number
    K121220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: 4969702 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S. 5128511 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 4976144 300-30-14 - EQUINOXE PRESERVE STEM 14MM. 4938029 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA). 5142727 315-35-00 - GLND KWIRE. H3: THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, G. THE REVISION REPORTED IN MAY HAVE BEEN THE RESULT OF THE GLENOID WEAR. A CONTRIBUTING FACTOR TO THE PROSTHESIS WEAR MAY BE THE GLENOID IMPLANT¿S NON-CONFORMING PACKAGING. POTENTIAL CONTRIBUTIONS OF PATIENT OR USER-RELATED ISSUES TO THE EVENT CANNOT BE DETERMINED FROM THE REPORTED INFORMATION. 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 THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 7 YEARS 4 MONTHS POST INITIAL OPERATION. PATIENT RETURNED TO SURGEONS OFFICE WITH PAIN, DECREASED ROM, AND LOSS OF STRENGTH. UPON REVISION, THE POLY WAS EXPLANTED AND THERE WAS SIGNIFICANT WEAR. WE CONVERTED TO REVERSE TOTAL SHOULDER ARTHROPLASTY, DJO BASEPLATE AND GLENOSPHERE, EXACTECH HUMERAL COMPONENTS, +0MM HUMERAL ADAPTER TRAY AND 36MM +0MM POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289579 LARGE, RIGHT 16 POST AUG UHMWPE GLENOID PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862228369

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization SEE H11.