BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 18877568 · Received March 11, 2024

    Report

    Report Number
    1038671-2024-00454
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    October 13, 2022
    Report Date
    July 23, 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) CONCOMITANT DEVICE(S): 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET: A124808 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: (B)(6) 320-15-05 - EQ REV LOCKING SCREW: A140243 320-15-06 - RS GLENOID PLATE EXT CAG +10MM CAGE PEG: 5885323 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: A125090 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: S370598 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: A061906 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: S373642 321-52-09 - 3.2MM K-WIRE, TROCAR TIP: (B)(6). (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. 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

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 64-YEAR-OLD MALE PATIENT HAD A LEFT TSA REVISION ON (B)(6) 2022. THE PATIENT PRESENTED WITH DEEP INFECTION, 0 YEAR(S) AND 1 MONTH(S) POST PROCEDURE ON (B)(6) 2022. PATIENT WAS ASSESSED FOR P-ACNES INFECTION DURING REVISION. CONFIRMED P-ACNES POST-OP REVISION VIA INTRA-OP CULTURES. PATIENT IS ON ORAL DOXYCYCLINE HYCLATE POST-OP FOR AT LEAST 6WEEKS. PATIENT HAD CONTINUED POST-OP REVISION PAIN IN THE SHOULDER. HAD AN EMG. EMG OVERALL NEGATIVE. CONTINUED POST-OP REVISION PAIN. REFERRED FOR SECOND OPINION. LOV WAS 12/22/2022. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE REPORT INDICATES THAT THE ACTION TAKEN IS MEDICATION & OTHER - NERVE STUDY. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076112 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male SEE H10