BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER COMPONENTS

    MDR report key: 17555578 · Received August 16, 2023

    Report

    Report Number
    1038671-2023-01961
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    January 1, 2023
    Report Date
    September 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 300-30-10 - EQUINOXE PRESERVE STEM 10MM, A089652 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, A148185 320-15-05 - EQ REV LOCKING SCREW, A162938 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, A140450 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM, A115928 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, A172619 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, A144168 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM, A187241 320-32-40 - EXPANDED GLENOSPHERE, 40MM, FOR SMALL REVERSE, A151285 320-35-07 - SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT, A132817.

    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, D4, G1, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, DISLOCATION, ROTATOR CUFF TEAR, AND/OR PATIENT RELATED FACTORS. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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 PATIENT WAS REVISED. REASON FOR THE REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528638 UNKNOWN SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10