BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY SIZE 3

    MDR report key: 8711104 · Received June 19, 2019

    Report

    Report Number
    1220246-2019-01150
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    January 11, 2016
    Report Date
    June 19, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    UDI-DI
    00888867106710
    PMA / PMN Number
    K081127
    Removal / Correction Number
    1220246-1/29/16-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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-TTTD AND LOT NUMBER 780838 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 VIA PATIENT LEGAL REPRESENTATIVE THAT A PATIENT HAD UNDERGONE A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2014. DURING THE 2014 PROCEDURE THE FOLLOWING DEVICES WERE IMPLANTED: AR-503-TTTD (LOT 780838) TIBIAL TRAY IMPLANT; AR-516-5L (LOT 1279940) FEMORAL IMPLANT; AR-513-BD12 (LOT 113601329) TIBIAL BEARING IMPLANT; AR-504-PSC9 (LOT 113601411) PATELLA IMPLANT. ON (B)(6) 2016 THE PATIENT UNDERWENT A REVISION LEFT TKA PROCEDURE DUE TO LOOSENING OF THE LEFT TOTAL KNEE. DURING THE REVISION PROCEDURE ALL ARTHREX IMPLANTS FROM THE (B)(6) 2014 PROCEDURE WERE EXPLANTED. THE SURGERY WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S PRODUCT. ADDITIONAL INFORMATION RECEIVED ON 5/29/2019: IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS DATED (B)(6) 2014 THAT THE PATIENT FELL DIRECTLY ON HER KNEE TWO WEEKS PRIOR TO THE FOLLOW UP APPOINTMENT. MEDICAL RECORDS DATED (B)(6) 2015 NOTE THAT THE PATIENT WAS DOING FAIR AND FUNCTIONALLY THE LEFT KNEE IS DOING WELL BUT SHE HAS HAD MULTIPLE FALLS FOR UNKNOWN CAUSES. SURGEON DISCUSSED THAT HER FALLS PLAY A SIGNIFICANT ROLE IN HER RECOVERY. ADDITIONAL MEDICAL RECORDS DATED (B)(6) 2015 NOTE THAT THE PATIENT'S BONE SCAN WAS POSITIVE FOR LOOSENING OF THE PROSTHESIS. PATIENT HAD A BMI OF APPROXIMATELY 40 AT THE TIME OF THE INDEX SURGERY AND REVISION SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507147 IBALANCE TKA TIBIAL TRAY SIZE 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 3 780838 00888867106710

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other