BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19122341 · Received April 16, 2024

    Report

    Report Number
    1038671-2024-00877
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 25, 2024
    Report Date
    July 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): 7075132 - 300-30-06 - EQUINOXE PRESERVE STEM 6MM. A134871 - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A163984 - 320-15-05 - EQ REV LOCKING SCREW. A112927- 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S380806 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. A172792 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S377754 - 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. A183631 - 320-31-36 - GLENOSPHERE, 36MM. A122745 - 320-35-01 - SMALL GLENOID PLATE. A108172 - 320-36-00 - 145-DEG PE 36MM HUM LINER +0.

    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, D6B, 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. NO EXPLANT DATE. THE CAUSE OF THE PATIENT¿S SHOULDER INSTABILITY AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. INSTABILITY IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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 75 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO INSTABILITY. THE SURGEON REMOVED A SMALL 36 GLENOSPHERE AND 36 LINER. HE REVISED TO A SMALL 40+4 GLENOSPHERE AND 40+2.5 LINER. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023399 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female SEE H10