BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12646673 · Received October 18, 2021

    Report

    Report Number
    1038671-2021-00543
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    August 4, 2021
    Report Date
    December 8, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    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

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF DISASSOCIATION OF THE HUMERAL LINER FROM THE HUMERAL ADAPTER TRAY. THE CAUSE OF THE DISASSOCIATION CANNOT BE DETERMINED AT THIS TIME BECAUSE THE REVISED COMPONENTS ARE NOT AVAILABLE FOR EVALUATION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D4) SERIAL NUMBER: (B)(6). (D11) CONCOMITANT DEVICE(S): 320-10-05, 6849309 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5. 320-20-00, 6862056 -EQ REVERSE TORQUE DEFINING SCREW KIT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE(S): 320-10-05, 6782101 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; 320-20-00, 7005391- EQ REVERSE TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT, THE (B)(6) Y/O MALE PATIENT RECEIVED A RIGHT RTSA ON (B)(6) 2021. THE PATIENT WAS HEALING FINE AND COMPLETING HIS POSTOP PT. APPROXIMATELY 4 MONTHS LATER, AROUND (B)(6), HE PUT HIS HAND DOWN ON A TABLE AND IT FELT LIKE IT DISLOCATED. HE PRESENTED TO THE SURGEON AND ON (B)(6) WAS REVISED. IT WAS NOTED THAT THE LINER WAS SEPARATED. THE PATIENT WENT ON TO DEVELOP A HEMATOMA AROUND (B)(6) AND RETURNED TO THE OPERATING ROOM TO DRAIN AND REPAIR THE HEMATOMA AND INCISION AREA. PER THE PATIENT, HE IS HEALING WELL NOW. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544062 EQUINOXE REVERSE 42MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-42-00 UNK 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R