BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19387579 · Received May 23, 2024

    Report

    Report Number
    1038671-2024-01447
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 12, 2024
    Report Date
    April 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM - 300-01-07 - (B)(6). RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET - 320-02-38 - (B)(6). EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 - 320-10-00 - (B)(6). EQ REV LOCKING SCREW - 320-15-05 - (B)(6). RS GLENOID PLATE +10MM CAGE PEG - 320-15-06 - 7103839 EQ REVERSE TORQUE DEFINING SCREW KIT - 320-20-00 - (B)(6). EQ REV LOCKING SCREW - 320-15-05 - A504422 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM - 320-20-22 - (B)(6). EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM -320-20-22 - (B)(6). EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM - 320-20-26 - S510534. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM - 320-20-26 - S512456. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM - 320-20-26 -- 0552. EQUINOXE REVERSE 38MM HUMERAL LINER +0 - 320-38-00 - S529321.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1 B2 D1 D4 G2 G4 H4 H6. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN . BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED. 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 75 Y/O FEMALE PATIENT'S LEFT SHOULDER WAS REVISED A WEEK POST OP DUE TO INFECTIONS. ALL IMPLANTS WERE REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850849 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| H