BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19913602 · Received August 5, 2024

    Report

    Report Number
    1038671-2024-02686
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 11, 2024
    Report Date
    June 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. D1: CORRECTED. H6: CORRECTED COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6) 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. (B)(6) 320-06-38 - GLENOSPHERE 38MM. (B)(6) 320-15-05 - EQ REV LOCKING SCREW. (B)(6) 320-38-13 - 145-DEG PE 38MM CONST HUM LINER +2.5. (B)(6) 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 70 YO MALE PATIENT, WHO HAD AN INITIAL LEFT REVERSE SHOULDER IMPLANTED IN (B)(6) 2021, WHO WAS REVISED IN (B)(6) 2024 FOR POLY DISASSOCIATION AND IN (B)(6) 2024 TO HAVE A SINGLE STAGE REVISION DUE TO INFECTION, UNDERWENT A 3RD REVISION IN (B)(6) 2024 TO REMOVE THE DEVICES DUE TO INFECTION. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS DUE TO HOSPITAL POLICY. NO DEVICE IMAGES WERE ABLE TO BE PROVIDED. NO FURTHER INFORMATION. (B)(6) 2024 POLY DISASSOCIATION REPORTED UNDER MDR#S 1038671-2024-00600/1038671-2024-00601 (B)(6) 2024 SINGLE STAGE REVISION REPORTED UNDER MDR# 1038671-2024-01266. CONCOMITANTS: A865871 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A945642 320-06-38 - GLENOSPHERE 38MM A973880 320-15-05 - EQ REV LOCKING SCREW A391407 320-38-13 - 145-DEG PE 38MM CONST HUM LINER +2.5 A671107 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674453 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H11