BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE 145-DEG PE 46MM HUM LINER +2.5

    MDR report key: 21358650 · Received February 11, 2025

    Report

    Report Number
    1038671-2025-00832
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    December 11, 2024
    Report Date
    October 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086747
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-13 - EQ, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 4259111 (REMAINED IMPLANTED FROM INDEX SURGERY ON (B)(6) 2016) 320-01-46 - EQUINOXE REV 46MM GLENOSPHERE: 2646032 320-15-01 - EQ REV GLENOID PLATE: 4211947 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, G THE REVISION REPORTED WAS LIKELY THE RESULT OF DISASSEMBLY BETWEEN THE HUMERAL LINER AND HUMERAL TRAY. HOWEVER, THIS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS FROM PATIENT CONDITIONS, AN UNREPORTED TRAUMATIC EVENT, INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE LINER AND GLENOID BONE (SCAPULAR NOTCHING), OR A COMBINATION OF THE ABOVE TO THE REPORTED DISASSEMBLY OF THE HUMERAL LINER CANNOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES/RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    APPROXIMATELY 8 YEAR(S), 4 MONTH(S) AND 2 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. PATIENT'S SHOULDER 'LOCKED UP' WHILE AT WORK WITH FEELINGS OF INSTABILITY THEREAFTER. THE PATIENT UNDERWENT A TENDON TRANSFER WITH ROTATOR CUFF REPAIR 3 MONTHS POST OPERATIVELY (SEE CASE-(B)(4) AND WAS REVISED APPROXIMATELY 5 MONTHS POST OPERATIVE OF THE INITIAL IMPLANTATION OF DEVICES FOR UNKNOWN REASONS. (SEE CASE-(B)(4) ONE MONTH AND FIVE DAYS FOLLOWING THE ONSET OF SYMPTOMS, THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH REPORTED REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED, AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845330 EQUINOXE 145-DEG PE 46MM HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086747

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization