BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 42MM CONST HUM LINER +2.5

    MDR report key: 20034945 · Received August 22, 2024

    Report

    Report Number
    1038671-2024-02983
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    February 12, 2020
    Report Date
    September 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086723
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 320-42-13 - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5: 5328719. 300-30-12 - EQUINOXE PRESERVE STEM 12MM: 5740799. 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 5610461. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 6017507. 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT: 6091511. 320-15-05 - EQ REV LOCKING SCREW: 6152805. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6115599. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 5673242. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 5923622. 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM: 5927194. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 6114925.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    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, G2, G3, G4, H4, H6, H11. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REVISION REPORTED WAS LIKELY THE RESULT OF DISASSEMBLY BETWEEN THE HUMERAL LINER AND HUMERAL TRAY AFTER AN ACUTE INJURY. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED AND POTENTIAL CONTRIBUTIONS FROM PATIENT CONDITIONS TO THE REPORTED DISASSEMBLY OF THE HUMERAL LINER CANNOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES/RADIOGRAPHS 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

    APPROXIMATELY 2 MONTH(S) AND 28 DAY(S) POST-OPERATIVE OF A LEFT TSA, THE PATIENT PRESENTED WITH DISASSOCIATION OF OTHER COMPONENT. PATIENT SUFFERED ACUTE INJURY IN LATE 2019. THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE WITH EXACTECH DEVICES. SUBSEQUENTLY, THE PATIENT PRESENTED WITH DISASSOCIATION OF OTHER COMPONENT. PATIENT SUFFERED ACUTE INJURY IN LATE 2019. AS A RESULT, APPROXIMATELY 3 MONTH(S) AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968536 145-DEG PE 42MM CONST HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK 10885862086723

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male SEE H11