BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 17451772 · Received August 3, 2023

    Report

    Report Number
    1038671-2023-01807
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    May 18, 2023
    Report Date
    July 17, 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

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3003008. REVERSE HUMERAL LINER 3203800. REVERSE HUMERAL TRAY 3201000. REVERSE GLENOSPHERE BASEPLATE 3201501.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED AND REFLECTED IN CHANGES TO B5, D1, D2A, D2B, D6A, D6B, D7A, AND H6. CONCOMITANT DEVICE(S): 320-38-00 - 145-DEG PE 38MM HUM LINER +0: (B)(6). 300-30-08 - EQUINOXE PRESERVE STEM 8MM: (B)(6). 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM: (B)(6). 320-06-38 - GLENOSPHERE 38MM: (B)(6). 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: (B)(6). 320-15-01 - EQ REV GLENOID PLATE: (B)(6). 320-15-05 - EQ REV LOCKING SCREW: (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: (B)(6). 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: (B)(6). 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: (B)(6). 321-52-07 - 3.2MM DRILL BIT STERILE: (B)(6). 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS: (B)(6). 620-12-02 - ACCELERATE PRP 60 ML & ACD-A: (B)(6). EXC-EQRV38-US - ORTHOSENSOR 38MM USA: (B)(6).

    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, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION 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. DISLOCATION 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

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 62 YO MALE PATIENT EXPERIENCED RE-OCCURRING DISLOCATIONS DUE TO SHOULDER INSTABILITY. THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WILL UNDERGO REVISION SURGERY IN THE NEAR FUTURE WITH RECOMMENDATIONS TO CONVERT TO LARGER GLENOSPHERE FOR IMPROVED SHOULDER STABILITY. THE OUTCOME WAS LAST KNOWN AS CONTINUING.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT APPROXIMATELY 1 YEAR(S), 2 MONTH(S) AND 25 DAY(S) POST-OPERATIVE OF A RIGHT TSA; THE PATIENT EXPERIENCED RE-OCCURRING DISLOCATIONS DUE TO SHOULDER INSTABILITY. THE PATIENT UNDERWENT REVISION SURGERY TO CONVERT TO LARGER GLENOSPHERE FOR IMPROVED SHOULDER STABILITY. THE OUTCOME IS NOW CONSIDERED RESOLVED AND THE CLINICAL STUDY REPORT INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICE(S) AND TO PROCEDURE(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508315 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK
    2127801 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O