BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20040064 · Received August 22, 2024

    Report

    Report Number
    1038671-2024-03011
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 1, 2024
    Report Date
    March 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3: A REVIEW OF THE STERILE CERTIFICATES FOR THE REVISED DEVICES WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO AN INFECTION. HOWEVER, THE REASON FOR THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED BASED ON THE INFORMATION PROVIDED. INFECTION IS A KNOWN POTENTIAL SURGICAL COMPLICATION. H6.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. A REVIEW OF THE STERILE CERTIFICATES FOR THE REVISED DEVICES WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO AN INFECTION. HOWEVER, THE REASON FOR THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED BASED ON THE INFORMATION PROVIDED. INFECTION IS A KNOWN POTENTIAL SURGICAL COMPLICATION. 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

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 6455821 300-01-17 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM A645960 315-35-00 - GLND KWIRE 4474173 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE B014626 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A994488 320-15-04 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT A874939 320-15-05 - EQ REV LOCKING SCREW A961558 320-15-05 - EQ REV LOCKING SCREW A914586 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A922453 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S510527 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S521279 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S532184 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM A420915 320-46-00 - EQUINOXE REVERSE 46MM HUMERAL LINER +0 A998995 321-52-09 - 3.2MM K-WIRE, TROCAR TIP A943766 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE B003612 531-78-20 - SHOULDR GPS HEX PINS KIT 12000723113 A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 2 MONTH POST OP. PATIENT PRESENTED TO ED WITH PAIN, SWELLING AND ACTIVE SINUS 9 WEEKS POST OP. USS ASPIRATE SHOWED NO OBVIOUS BACTERIA. DAIR PROCEDURE PERFORMED WITH OXFORD PROTOCOL. ADAPTER TRAY AND LINER WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: SENT TO RPH FOR STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27058 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention| H SEE H11.