BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 18757238 · Received February 22, 2024

    Report

    Report Number
    1038671-2024-00286
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 31, 2024
    Report Date
    May 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: THE CAUSE OF THE PATIENT¿S INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. GENERAL SURGICAL RISKS INCLUDE SUPERFICIAL OR DEEP INFECTION AND DELAYED WOUND HEALING. IT IS A KNOWN COMPLICATION THAT A PATIENT¿S AGE, WEIGHT, ACTIVITY LEVEL, AND/OR TRAUMA WOULD CAUSE THE SURGEON TO EXPECT EARLY FAILURE OF THE SYSTEM. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 5442391 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET. 6730018 320-42-13 - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5. 7292345 315-35-00 - GLND KWIRE A000416 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM . A051984 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A085077 320-15-05 - EQ REV LOCKING SCREW.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1, D4: EXPIRATION DATE IS UNKNOWN AND HAS BEEN LEFT BLANK, H4: DEVICE MANUFACTURING DATE IS UNKNOWN AND HAS BEEN LEFT BLANK, H6. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. 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

    AS REPORTED, THE PATIENT HAD A PREVIOUS RIGHT SIDE REVISION ON (B)(6) 2022. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2024 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139790 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.
    1416302 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention SEE H10