BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 22476232 · Received July 10, 2025

    Report

    Report Number
    1038671-2025-02481
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    February 10, 2023
    Report Date
    July 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-30-14 - EQUINOXE PRESERVE STEM 14MM: 5623800, 320-42-00 - 145-DEG PE 42MM HUM LINER +0: S389808, 320-10-05 - EQUINOXE REVERSE ADAPTER PLATE TRAY +5: A084553, 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET: A203815, 320-15-05 - EQ REV LOCKING SCREW: A235657, 320-15-01 - EQ REV GLENOID PLATE: A162284. 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 REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. 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

    D1: CORRECTED H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES. H10: CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. TWO MONTHS FOLLOWING, THIS PATIENT UNDERWENT A RIGHT SHOULDER REVISION DUE TO A DISLOCATION FROM A FALL. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ADDITIONAL DISLOCATION WITH NO CITED EVENT OR INJURY. PATIENT WAS NON-COMPLIANT WITH PRESCRIBED SLING WEAR AND PHYSICAL THERAPY. AS A RESULT, APPROXIMATELY TWO MONTHS AFTER PREVIOUS REVISION, THE PATIENT UNDERWENT A CLOSED REDUCTION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996026 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.