BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5

    MDR report key: 10842940 · Received November 16, 2020

    Report

    Report Number
    1220246-2020-02335
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    August 10, 2020
    Report Date
    November 16, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBH
    UDI-DI
    00888867187887
    PMA / PMN Number
    K152252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDICAL PROFESSIONAL THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE (B)(6) 2018. THE PATIENT LATER UNDERWENT A REVISION TKA PROCEDURE SOMETIME IN (B)(6) 2020. ADDITIONAL INFORMATION OBTAINED 10/27/2020: AN ARTHREX SALES REP HAS OBTAINED AND PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: PATIENT HAD REPORTED TO A DIFFERENT SURGEON AS HAVING PAIN ON THE OPERATIVE SIDE. THE SECOND SURGEON PERFORMED A REVISION TKA, (B)(6) 2020 AND REVISED THE TIBIAL COMPONENT. THE FEMUR WAS FOUND TO BE WELL FIXATED AT THE TIME OF REVISION. THE FOLLOWING ORIGINAL IMPLANT DEVICES WERE EXPLANTED AT THE TIME OF REVISION: AR-513-T5, IBALANCE TKA TIBIAL TRAY, LOT 10183321, AR-523-B510, IBALANCE TKA TIBIAL BEARING IMPLANT (SIZE 5), LOT 5791643. THE FOLLOWING ORIGINAL IMPLANT DEVICES WERE LEFT IN THE PATIENT AT THE TIME OF REVISION: AR-516-6L, IBALANCE TKA FEMORAL IMPLANT, LOT 10053281, AR-524-PSC9, IBALANCE PATELLA IMPLANT, LOT 132581743. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF REVISION: AR-513-T4, IBALANCE TKA MODULAR TIBIAL TRAY, LOT 10572760, AR-513-BE-16, IBALANCE TKA BEARING IMPLANT (SIZE 4), LOT 113601819, AR-513-1050. IBALANCE TKA TIBIAL STEM, LOT 10018103.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313444 IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5 10183321 00888867187887

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other