BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 8864886 · Received August 6, 2019

    Report

    Report Number
    1038671-2019-00395
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    October 1, 2014
    Report Date
    September 16, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN FOUND TO BE A DUPLICATE OF THE FOLLOWING MFR NUMBERS 1038671-2017-0000690, 1038671-2017-0000691 AND 1038671-2017-0000692. THIS REPORT CAN BE COMPLETED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICES: (CN: 204-36-08, SN: NOT REPORTED) STEM EXTENSION 80L X16 MM; (CN: 208-23-13, SN: NOT REPORTED) CC TIBIAL INSERT SZ 3, 13MM; (CN: 204-04-33, SN: NOT REPORTED) TRAPEZOID TIBIAL TRAY SZ 3F/3T; (CN: 204-36-12, SN: NOT REPORTED) STEM EXTENSION W/SLOT 120L X16 MM; (CN: 204-63-88, SN: NOT REPORTED) TIBIAL AUGMENT BLOCK 1/2-SZ 3 11MM RLLM; (CN: 204-63-89, SN: NOT REPORTED) TIBIAL AUGMENT BLOCK 1/2-SZ 3 11MM ; (CN: 208-09-05, SN: NOT REPORTED) CC STEM EXT ADAPTOR 5 DEGREE; (CN: NOT REPORTED, SN: NOT REPORTED) PATELLA.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2013. REVISION DUE TO WOUND INFECTION AND PATELLA FRACTURE IMPLANT REMOVAL AND INTRODUCTION OF A SPACER. THE CASE REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY NOT TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THE CASE REPORT INDICATES THE CASE WAS RESOLVED WITH REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658166 OPTETRAK CC FEMORAL SZ 3 JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SEE H10.