BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12358302 · Received August 24, 2021

    Report

    Report Number
    1038671-2021-00407
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    August 3, 2021
    Report Date
    October 22, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF THE DISLOCATION AND THE HUMERAL LINER DISASSOCIATION. IT IS UNCLEAR IF THE DISLOCATION ALLOWED FOR THE HUMERAL LINER TO DISASSOCIATE OR IF THE HUMERAL LINER DISASSOCIATION- WHICH MAY HAVE BEEN THE RESULT OF EITHER INCOMPLETE SEATING OF THE LINER DURING THE FIRST REVISION SURGERY, BONE IMPINGEMENT, PATIENT CONDITIONS, OR A COMBINATION OF THE THREE- LED TO THE DISLOCATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE(S): 320-20-00, 5873052 - EQ REVERSE TORQUE DEFINING SCREW KIT; 320-42-00, 6507026 - EQUINOXE REVERSE 42MM HUMERAL LINER +0.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 1 YR POSTOP A REVISION OF RTSA DUE TO TRAUMATIC DISLOCATION, THIS (B)(6) Y/O MALE PATIENT WAS SEEN BY DR. (B)(6) FOR A ROUTINE FOLLOW-UP RECENTLY WHERE IT WAS FOUND HIS SHOULDER WAS DISLOCATED. A REVISION WAS COMPLETED. DURING SURGERY IT WAS FOUND THAT THE LINER HAD AGAIN DISASSOCIATED FROM THE TRAY. NO TRAUMATIC EVENT WAS REPORTED BY THE PATIENT SINCE THE INITIAL REVISION. DURING THE MOST RECENT REVISION THE TRAY TORQUE SCREW AND LINER WERE EXPLANTED AND REPLACED. EXPLANTED IMPLANTS WILL BE RETURNED FOR EVALUATION. THE SURGEON¿S CONCERN IS THAT WITH THE INITIAL TRAUMATIC EVENT, WHICH DISASSOCIATED THE LINER, MANY HAVE DAMAGED THE LOCKING MECHANISM OF THE TRAY AND CAUSED THE SUBSEQUENT LINER IMPLANTED TO DISSOCIATE FROM THE TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. DEVICES WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255753 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 KWT EXACTECH, INC. 320-10-00 UNK 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R SEE H10