BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8859579 · Received August 5, 2019

    Report

    Report Number
    1038671-2019-00388
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 12, 2019
    Report Date
    October 7, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086488
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10:C (G5) PMA/510(K)NUMBER: K063569. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF INFECTION. ANY ¿SURGICAL SITE¿ INFECTION NOTED IN A PATIENT THAT IS GREATER THAN 3 MONTHS POSTOP FROM A TOTAL JOINT SURGICAL PROCEDURE IS HIGHLY UNLIKELY TO BE RELATED TO THE SURGICAL PROCEDURE FOR PLACEMENT OF THE TOTAL JOINT OR THE DEVICE ITSELF [1]. THE REPORTED INFECTION OCCURRED GREATER THAN 6 MONTHS AFTER THE INDEX SURGERY. THEREFORE, NEITHER THE DHR NOR THE STERILIZATION RECORDS WERE REVIEWED. 1. ACUTE INFECTION IN TOTAL KNEE ARTHROPLASTY: DIAGNOSIS AND TREATMENT JUAN CARLOS MARTÍNEZ- PASTOR,* FRANCISCO MACULÉ-BENEYTO, AND SANTIAGO SUSO-VERGARA. OPEN ORTHOP J. 2013; 7: 197¿204. PUBLISHED ONLINE 2013 JUN 14. SUPERFICIAL OR DEEP INFECTION IS COVERED UNDER GENERAL SURGICAL RISKS SECTION IN THE EQUINOXE SHOULDER SYSTEM IFU 700-096-060 REV M. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (G4) DATE RECEIVED BY MANUFACTURER: 18-SEP-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 306-02-08, 2257605, HUMERAL LONG STEM; 320-02-42, 2285210, EXPANDED 42MM GLENOSPHERE; 320-10-10, 2210366, EQU. ADAPTER TRAY +10; 320-20-00, 3236253, TORQUE SCREW KIT; 320-20-22, 2209959, 22MM COMP. SCREW; 320-20-30, 2207947, 30MM COMP. SCREW; 320-20-38 ,2187042, 38MM COMP. SCREW; 320-20-42, 2276048, 42MM COMP. SCREW; 320-20-46, 2229505, 46MM COMP. SCREW; 320-42-03, 2180550, HUMERAL LINER, 42MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT REPORTED TO THE SURGEON ¿PAINFUL REVERSE SHOULDER REPLACEMENT¿. REPORTEDLY, THE SHOULDER SEEMED STABLE AND FILMS (NOT AVAILABLE) DID NOT SHOW ANY SIGNS OF PROBLEM. CULTURES WERE TAKEN TO CHECK FOR INFECTION AND CAME BACK POSITIVE FOR P. ACNES. SURGEON DECIDED TO REMOVE ALL COMPONENTS AND PLACE A MOLDED ANTIBIOTIC SPACER. REMOVAL OF COMPONENTS WAS DONE WITH NO ISSUE PER STANDARD OPERATIVE TECHNIQUES. PATIENT WAS STABLE WHEN LEFT OR. NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653750 EQUINOXE REV GLENOID PLATE KWT EXACTECH, INC. 10885862086488

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention