BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 19629991 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02197
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    April 10, 2024
    Report Date
    July 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-46-00 - 145-DEG PE 46MM HUM LINER +0: 6978594, 320-06-46 - GLENOSPHERE 46MM: 6587991, 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 6449837, 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 7026561, 320-15-05 - EQ REV LOCKING SCREW: 7104540, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 7079151, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: S243027, 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM: S203797, 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM: 6276267, 321-52-07 - 3.2MM DRILL BIT STERILE: 6538487, 531-20-00 - SHLDR GPS RVRS DRILL KIT: 6890547, 531-78-20 - SHOULDR GPS HEX PINS KIT: 7070340, A10012 - GPS IMPLANT KIT V2: 06010721343.

    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, G4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. 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

    APPROXIMATELY 2 YEARS AND 4 MONTHS AFTER INITIAL LEFT TSA, PATIENT DISLOCATED HIS SHOULDER DOING BICEP CURLS. THE PATIENT'S SHOULDER WAS REVISED BY STANDARD TOTAL REVISION AND THE OUTCOME IS CONSIDERED RESOLVED. THE CASE REPORT INDICATES THAT THE EVENT IS POSSIBLY RELATED TO DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184995 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male SEE H11