BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20657980 · Received November 11, 2024

    Report

    Report Number
    1038671-2024-04346
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    December 30, 2022
    Report Date
    July 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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

    (D10) REPORTED CONCOMITANT DEVICE(S): 320-42-10 - 145-DEG PE 42MM CONST HUM LINER +0 5974817, 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5 A084526, 308-12-00 - MED PROX BODY +12.5 6619182.

    Description of Event or Problem · 0

    APPROXIMATELY 4 MONTH(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ANOTHER DISLOCATION. SUBJECT REPORTS A POP DURING STRETCHING EXERCISES IN POSTOPERATIVE PHYSICAL THERAPY APPOINTMENT. AFTER VISITING A WALK-IN ORTHOPAEDIC CLINIC, X-RAYS REVEALED A DISLOCATED PROTHESES. THE SUBJECT WAS GIVEN MEDICATION, AND THE SUBJECT WILL BE SCHEDULED FOR REVISION SURGERY TO CONVERT TO HEMIARTHROPLASTY. THE OUTCOME OF THIS EVENT REMAINS CONTINUING AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134612 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other SEE H11.