BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    MDR report key: 19516160 · Received June 11, 2024

    Report

    Report Number
    1038671-2024-01907
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    July 30, 2020
    Report Date
    January 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 5335144, 320-15-05 - EQ REV LOCKING SCREW: 6113806, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6274444.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2024-03450.

    Description of Event or Problem · 0

    STUDY: EQUINOXE SHOULDER STUDY SUBJECT: PHF-368L-REV1 RELATED TO: CASE (B)(6) , CASE (B)(6) IMPLANT DATE: ON (B)(6) 2020 EX-PLANT DATE: ON (B)(6) 2020 DATE OF EVENT ONSET: 07-30-2020. AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 0 YEAR(S) AND 5 MONTH(S) POST IMPLANTATION OF LEFT REVISED TSA (REVISION REPORTED ON CASE(B)(6) ), THE PATIENT PRESENTED WITH DISASSOCIATION OF POLYETHYLENE - STANDARD REVERSE. THIS OUTCOME OF THE EVENT WAS RESOLVED BY STANDARD REVERSE REVISION OF THE LEFT SHOULDER. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED. P/N: 320-42-00 DEVICE NAME: EQUINOXE REVERSE 42MM HUMERAL LINER +0 S/N: (B)(6) 510K: K063569 UDI: (B)(4) PRODUCT CODE: KWT P/N: 320-10-00 DEVICE NAME: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 S/N: (B)(6) 510K: K063569 UDI: (B)(4) PRODUCT CODE: KWT CONCOMITANTS: 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 5335144 320-15-05 - EQ REV LOCKING SCREW: 6113806 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6274444 HUMERAL STEM AND BASEPLATE NOT REPLACED. 74 Y/O MALE (2018) HEIGHT : 173 CM WEIGHT : 101 KGS BMI : 34 DIAGNOSIS : OSTEOARTHRITIS COMORBIDITIES : HYPERTENSION 2 CORTICOSTEROID INJECTIONS UNSPECIFIED ANALGESIC USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622789 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male SEE H11.