BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM

    MDR report key: 19855588 · Received July 29, 2024

    Report

    Report Number
    1038671-2024-02575
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    June 26, 2024
    Report Date
    April 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K042021
    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 - EQUINOXE REVERSE 42MM HUMERAL LINER +0: 3817259; 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: 3818143; 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 3826629; 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE: 3813161; 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 3820949; 320-15-05 - EQ REV LOCKING SCREW: 3794235; 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 3831719; 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 3821773; 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 3781323; 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM: 3792894; 315-35-00 - GLND KWIRE: 3810386; 315-35-00 - GLND KWIRE: 3832756.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF HUMERAL LOOSENING. THE REPORTED HUMERAL LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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. 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 9 YEAR(S), 1 MONTH(S) AND 3 DAY(S) POST-OPERATIVE OF A REVISED RIGHT TSA, THE PATIENT PRESENTED WITH ASEPTIC HUMERAL LOOSENING. THE PATIENT HAD A GRADUAL INCREASE IN PAIN OVER LAST 3-4 MONTHS-LOOSE STEM IN PREVIOUSLY REVISED SHOULDER. THE PATIENT UNDERWENT STANDARD REVERSE REVISION SURGERY, AND THE OUTCOME IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015664 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male SEE H11.