BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

    MDR report key: 20044751 · Received August 22, 2024

    Report

    Report Number
    1038671-2024-03026
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    December 5, 2019
    Report Date
    August 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079312
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-32-36 - EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE: 6176176 320-35-07 - SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT: 6169021 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED: 6207450 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 5686361 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 6251809 320-15-05 - EQ REV LOCKING SCREW: 6217492 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6224279 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 5601146 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 6221857 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 6185927 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 6248382 531-20-00 - SHLDR GPS RVRS DRILL KIT: 6248648 531-78-20 - SHOULDR GPS HEX PINS KIT: 6260535 A10012 - GPS IMPLANT KIT V2: 10000219180 ASA0030 - STERILE DISPOSABLE CONTAINERS: AB5353 CNL-09 - SMALL CEMENT CANNULA: AB3449 13A2101 - CEMEX SYSTEM FAST GENTA 70G: AB4106.

    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, G4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. THE REASON FOR THE POST OPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO IMPLANT POSITIONING, PATIENT BONE QUALITY, A TRAUMA, AND/OR ANOTHER PATIENT RELATED CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION 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

    POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A HUMERAL FRACTURE. AVULSION OF THE GREATER TUBEROSITY, AND IT IS NOW DISPLACED POSTERIORLY AND SUPERIORLY. THE PATIENT WAS GIVEN MODIFIED PHYSICAL THERAPY PROTOCOL. THE PATIENT IN NO PAIN, FRACTURED APPEARS HEALED ON X-RAY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698538 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862079312

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female SEE H11.