BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 17451930 · Received August 3, 2023

    Report

    Report Number
    1038671-2023-01805
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    October 11, 2021
    Report Date
    July 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3000111. REVERSE HUMERAL LINER 3203800. REVERSE HUMERAL TRAY 3201000. REVERSE GLENOSPHERE BASEPLATE 3201502.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, D4, G4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. EXPLANT DATE IS NOT KNOWN. THE REASON FOR THE REPORTED SUSPECTED 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

    IT WAS REPORTED POST-OP VIA CLINICAL STUDY THAT THE 78 YO FEMALE PATIENT WAS SUSPECTED TO HAVE AN INFECTION WITH INCREASED PAIN AND RAISED INFLAM MARKERS. HOWEVER, MORE RECENT BLOOD TESTS, AND NO PROGRESSION ON X-RAY, SUGGESTS NO INFECTION. THERE WAS NO ACTION TAKEN. WILL CONTINUE TO WATCH. THE DATE OF EVENT ONSET IS (B)(6) 2021. THE OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318712 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| O