BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12646583 · Received October 18, 2021

    Report

    Report Number
    1038671-2021-00542
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    September 28, 2021
    Report Date
    May 10, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086747
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D4) CATALOG NUMBER: 320-46-03, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 02-JUN-2025, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G4) PMA/510(K)NUMBER: K063569. (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF EITHER INCOMPLETE SEATING OF THE LINER DURING IMPLANTATION, BONE IMPINGEMENT, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO HUMERAL LINER DISASSOCIATION FOLLOWED BY DISLOCATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND X-RAYS WERE NOT PROVIDED. (H4) DEVICE MANUFACTURE DATE: 04-JUN-2020 SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D11) CONCOMITANT DEVICE(S): 300-30-06, 6591180 - EQUINOXE PRESERVE STEM 6MM. 320-02-46, 6480692 - 46X21MM GLENOSPHERE HIGH MOMENT ARM. 320-10-00, 6623446 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION CONCOMITANT DEVICE(S): 300-30-06, 03066166 - EQUINOXE PRESERVE STEM 6MM +0 ADAPTER TRAY. 320-02-46, 292248010 - 46X21MM GLENOSPHERE HIGH MOMENT ARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LINER DISASSOCIATED FROM THE HUMERAL TRAY CAUSING THE (B)(6) MALE PATIENT'S SHOULDER TO DISLOCATE. THE SURGEON REVISED THE LEFT SIDE GLENOSPHERE TO A 42+4. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545164 EQUINOXE 46 NEUTRAL HUMERAL LINER KWT EXACTECH, INC. UNK UNK 10885862086747

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R