BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY SIZE 5

    MDR report key: 8964735 · Received September 5, 2019

    Report

    Report Number
    1220246-2019-01298
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 14, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    UDI-DI
    00888867106734
    PMA / PMN Number
    K081127
    Removal / Correction Number
    1220246-1/29/16-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED. THE CATALOG NUMBER, AR-503-TTTF AND LOT NUMBER 971202 ASSOCIATED WITH THIS EVENT HAS BEEN INVOLVED IN RECALL NUMBER 1220246-1/29/16-001-R. THE INFORMATION RECEIVED REGARDING THE EVENT IS NOT SUFFICIENT TO DETERMINE THE CAUSE OF THE EVENT OR WHETHER IT HAD ANY RELATION TO THE RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE 2014 PROCEDURE THE PATELLA WAS NOT RESURFACED AND THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: TIBIAL TRAY, AR-503-TTTF, (LOT 971202); FEMORAL IMPLANT, AR-503-PSRF, (LOT 108761207); BEARING IMPLANT, AR-503-BF12, (LOT 113601237). ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION RIGHT TKA PROCEDURE. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: REVISION WAS DUE TO TIBIAL LOOSENING. ALL ORIGINAL 2014 DEVICES WERE EXPLANTED DURING THE REVISION. THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCTS. THE DEVICES WILL NOT BE RETURNING FOR EVALUATION AS IT WAS REPORTED BY THE SALES REP THAT RETURNING THE DEVICES IS AGAINST HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759531 IBALANCE TKA TIBIAL TRAY SIZE 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 5 971202 00888867106734

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other