BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12453105 · Received September 10, 2021

    Report

    Report Number
    1038671-2021-00470
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    November 20, 2020
    Report Date
    March 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (A4) PATIENT WEIGHT: 225 POUNDS (H3) UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED MALFUNCTION AND THERE IS NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT SCAPULAR NOTCHING AND DISLOCATION. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-01-38, 5680115 - EQUINOXE REVERSE 38MM GLENOSPHERE. 320-10-00, 5944251- EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-15-05, 5960580 - EQ REV LOCKING SCREW. 320-20-00, 5955988 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 18 MONTHS POSTOP THE INITIAL IMPLANT, THIS (B)(6) MALE PATIENT HAD A DISSOCIATION OF THE LINER FROM THE HUMERAL TRAY IN LEFT SHOULDER AND WAS REVISED. NO REASON REPORTED; HOWEVER, THE SURGEON WANTS THE LOCKING MECHANISM CHECKED ON THIS TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353249 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R