BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10559625 · Received September 21, 2020

    Report

    Report Number
    1038671-2020-00530
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    June 8, 2012
    Report Date
    December 3, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086747
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR THE MANUFACTURING PROCESS. THE CAUSE OF THE EVENT AND SUBSEQUENT REVISION, IS MOST LIKELY IS RELATED TO THE PATIENT¿S CONDITION AND THIS PATIENT LIKELY DID NOT KNOW OF HIS ALLERGY TO METAL ALLERGY OR DID NOT REPORT IT TO HIS SURGEON. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: ON (B)(6) 2011, THIS MALE PATIENT UNDERWENT IMPLANTATION OF AN EXACTECH REVERSE TOTAL SHOULDER REPLACEMENT. APPROXIMATELY 6 MONTHS LATER, (B)(6)2012, THE PATIENT WAS REVISED TO REMOVE ALL SHOULDER DEVICES CONTAINING METAL TO RESOLVE A NEWLY DIAGNOSED METAL ALLERGY. THE SURGEON DECIDED TO TEMPORARILY IMPLANT DEVICES TO PRESERVE THE SPACE AND THE PATIENT¿S ANATOMY WHILE THE CUSTOM CERAMIC GLENOSPHERE IMPLANT IS BEING MANUFACTURED. (D11) CONCOMITANT DEVICE(S): 320-10-05, 2181104 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5, 320-15-05, 2197059 - EQ REV LOCKING SCREW , 320-20-00, 2218161 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 0

    ON (B)(6) 2011, THIS MALE PATIENT UNDERWENT IMPLANTATION OF AN EXACTECH REVERSE TOTAL SHOULDER REPLACEMENT. APPROXIMATELY 6 MONTHS LATER, (B)(6)2012, THE PATIENT WAS REVISED TO REMOVE ALL SHOULDER DEVICES CONTAINING METAL TO RESOLVE A NEWLY DIAGNOSED METAL ALLERGY. THE SURGEON DECIDED TO TEMPORARILY IMPLANT DEVICES TO PRESERVE THE SPACE AND THE PATIENT¿S ANATOMY WHILE THE CUSTOM CERAMIC GLENOSPHERE IMPLANT IS BEING MANUFACTURED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    SECOND REVISION TO RESOLVE METAL ALLERGY EVENT WAS FOUND WHILE INVESTIGATING (B)(4). K063569. CONCOMITANT DEVICES: 320-10-05, 2181104 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; 320-15-05, 2197059 - EQ REV LOCKING SCREW; 320-20-00, 2218161 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028462 EQUINOXE REVERSE 46MM HUMERAL LINER +2.5 KWT EXACTECH, INC. 320-46-03 UNK 10885862086747

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R