BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT

    MDR report key: 17475891 · Received August 7, 2023

    Report

    Report Number
    1038671-2023-01886
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    October 4, 2023
    Report Date
    June 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862186690
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: REVERSE GLENOSPHERE BASEPLATE 3201504. HUMERAL STEM OR STEMLESS 3000113. REVERSE HUMERAL LINER 3203803. REVERSE HUMERAL TRAY 3201000.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE PAIN REPORTED MAY BE DUE TO A COMBINATION OF ASEPTIC (NON-INFECTED) GLENOID LOOSENING AND THE PATIENT¿S CERVICAL SPINE PATHOLOGY. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE NO RADIOGRAPHS WERE PROVIDED, AND THE PATIENT HAS NOT BEEN REVISED. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 4755, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    D10: 300-01-13 - EQ HUMERAL STEM PRIMARY, PRESS FIT 13MM: (B)(6). 320-38-03 - EQUINOXE REV 38MM HUMERAL LINER +2.5: (B)(6). 320-10-00 - EQUINOXE REVERSE ADAPTER PLATE TRAY +0: (B)(6). 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: (B)(6). 320-15-05 - EQ REV LOCKING SCREW: (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D7A, D10, G3, AND H11. THE FOLLOWING SECTIONS WERE CORRECTED: A2, B1, B5, D1, D4 - CATALOG, EXP. DATE, UDI#, H4, H6 - CLINICAL AND IMPACT CODES, TYPE OF INVESTIGATION, FINDINGS AND CONCLUSIONS. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A REVIEW OF COMPLAINT HISTORY WAS UNABLE TO BE PERFORMED AS THE RELEVANT DEVICE AND EVENT INFORMATION WAS UNKNOWN. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY BE DUE TO A COMBINATION OF ASEPTIC (NON-INFECTED) GLENOID LOOSENING AND THE PATIENT¿S CERVICAL SPINE PATHOLOGY. HOWEVER, THE LOOSENING CANNOT BE CONFIRMED AND ANY POTENTIAL CONTRIBUTIONS FROM USER, OR PATIENT-RELATED CONTRIBUTING FACTORS TO THE EVENT CANNOT BE EVALUATED AS NO RADIOGRAPH, IMAGES, OR CLINICAL INFORMATION WAS 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

    IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 18 MONTHS POSTOP THE INITIAL IMPLANT, THIS 73 YO MALE PATIENT WAS EXPERIENCING SEVERE PAIN FOR 2 MONTHS. X-RAY RESULT SHOWS AN ASEPTIC GLENOID LOOSENING. PATIENT WAS PRESCRIBED SOFT REHABILITATION INVOLVING SHOULDER AND SPINE AS HE SUFFERS FROM CERVICAL SPINE PATHOLOGY WHICH COULD EXPLAIN THE PAIN. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH SEVERE PAIN "EVOLVING SINCE 2 MONTHS POST-OPERATIVE". X-RAY SHOWS AN ASEPTIC GLENOID LOOSENING. AS A RESULT, THE PATIENT WAS PRESCRIBED SOFT REHABILITATION INVOLVING SHOULDER AND SPINE AS HE SUFFERS FROM CERVICAL SPINE PATHOLOGY WHICH COULD EXPLAIN THE PAIN; HOWEVER, APPROXIMATELY 1.5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280672 EQUINOXE RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862186690

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other| R SEE H10.| SEE H11.