BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 19858012 · Received July 29, 2024

    Report

    Report Number
    1038671-2024-02581
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    April 4, 2024
    Report Date
    August 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    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): 320-42-00 - 145-DEG PE 42MM HUM LINER +0 (B)(6). 300-30-08 - EQUINOXE PRESERVE STEM 8MM (B)(6). 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET (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). 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6). 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM (B)(6). (B)(6) - GPS IMPLANT KIT V2 10099121367. EXC-EQRV42-US - ORTHOSENSOR 42MM USA (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 - IMPACT CODE, INVESTIGATION SECTION. THE FOLLOWING SECTIONS WERE CORRECTED: A2 - REMOVAL OF DATE OF BIRTH, H6 - COMPONENT CODE. 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: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE POST OPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO IMPLANT POSITIONING, PATIENT BONE QUALITY, A TRAUMA, AND/OR ANOTHER PATIENT RELATED CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION 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 1 YEAR(S) AND 5 MONTH(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH ACROMIAL FRACTURE. THE PATIENT DENIES ANY TRAUMATIC EVENTS. STARTED OVER TIME - PAIN WAS WORSENING AND THEN HAD MUCH GREATER PAIN ABOUT 1-2 WEEKS AGO WITH DIFFUSE ECCHYMOSIS ACROSS HIS SHOULDER REGION. PAIN CAN BE MODERATE TO SEVERE. NO ACTION WAS TAKEN AND THE DEVICE(S) REMAIN IMPLANTED. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281862 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male SEE H11.