BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANATOMIC SHOULDER METAL COMPONENT

    MDR report key: 25280514 · Received May 26, 2026

    Report

    Report Number
    1038671-2026-00647
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    February 16, 2026
    Report Date
    May 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 1400-AG - CEMEX GENTO LOW VISCOSITY 40G KIT: AA7754. 300-01-15 - EQ, HUMERAL STEM PRIMARY, PRESS FIT 15 MM: 3759094. 300-10-45 - EQ REPLICATOR PLATE 4.5 MM O/S: 3780412. 300-20-02 - EQ SQUARE TORQUE DEFINE SCREW DRIVE KIT: 3812128. 310-01-47 - EQ, HUMERAL HEAD SHORT, 47 MM (BETA): 3726421. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER REPLACEMENT AND WAS SUBSEQUENTLY REVISED. DURING THE REVISION PROCEDURE, THE GLENOID EXHIBITED METALLOSIS. THE GLENOID CAGE WAS NOTED TO BE LOOSE AND DID NOT REQUIRE THE USE OF PEG EXTRACTORS FOR REMOVAL. THERE WAS NOTED WEAR. ALL IMPLANTED COMPONENTS WERE EXPLANTED. THE SURGEON IMPLANTED A COMPETITOR¿S HUMERAL COMPONENTS ALONG WITH A CUSTOM GLENOID COMPONENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102014 UNKNOWN ANATOMIC SHOULDER METAL COMPONENT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1