BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL BEARING, SIZE 3, 13MM, VIT E

    MDR report key: 11116751 · Received January 5, 2021

    Report

    Report Number
    1220246-2021-02441
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    December 14, 2020
    Report Date
    February 8, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBH
    UDI-DI
    00888867232396
    PMA / PMN Number
    K153586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS FOUND TO HAVE DAMAGED AND BROKEN POSTERIOR LOCKING TABS, DAMAGED ANTERIOR LOCKS, AND A HEAVILY WORN INFERIOR POSTERIOR SURFACE. HEAVY WEAR WAS ALSO OBSERVED ON THE ANTERIOR SIDE OF THE PEG. THE CAUSE OF THE DISENGAGEMENT OF THE BEARING FROM THE TIBIAL TRAY IS UNDETERMINED AND IS LIKELY DUE TO DAMAGE TO THE POSTERIOR LOCKING TABS, EITHER DURING INSERTION OR A SUBSEQUENT EVENT. THE HEAVY INFERIOR WEAR AND PEG WEAR LIKELY OCCURRED AS A RESULT OF THE BEARING DISENGAGEMENT.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE PROBABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. ADDITIONALLY, THE RISK WAS UNABLE TO BE ASSESSED AS THE COMPLAINT WAS UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE A PATIENT HAD UNDERGONE A TKA PROCEDURE (B)(6) 2020. DURING THE JUNE 2020 PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-513-T3, IBALANCE TKA MODULAR TIBIAL TRAY (LOT 10506044), AR-523-B313, IBALANCE TKA BEARING IMPLANT (LOT 5791824), AR-526-6R, IBALANCE FEMORAL IMPLANT (LOT 10259480), AR-524-PSB8, PATELLA IMPLANT DOME (LOT 132581845). ROUGHLY 6 MONTHS POST OP PATIENT BEGAN HAVING ISSUES WITH FULLY EXTENDING THE KNEE. IT WAS REPORTED THERE WAS A POST-OP DISENGAGEMENT OF THE POLY FROM THE TRAY. AT TIME OF REPORT THERE IS NO REVISION SURGERY SCHEDULED AND THE ARTHREX PRODUCTS REMAIN IN THE PATIENT. ADDITIONAL INFORMATION OBTAINED 12/2/20: PATIENT'S REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020. ADDITIONAL INFORMATION OBTAINED 12/15/20: THE PATIENT'S REVISION PROCEDURE TOOK PLACE AS PLANNED (B)(6) 2020. THE SURGEON WAS ABLE TO MAINTAIN THE EXISTING FEMORAL AND TIBIAL COMPONENTS WHILE JUST REPLACING THE ORIGINAL POLY BEARING, AR-523-B313 (LOT 5791824). AFTER NORMAL EXPOSURE THE SURGEON FOUND THE POLY EXTRUDING ANTERIORLY 1-2 CM, CONSISTENT WITH HIS ASSESSMENT OF PRE-OP X-RAYS. THE POLY WAS REMOVED AND REPLACED WITH THE SAME SIZE COMPONENT, A SIZE 3 / 13MM POLY. AFTER CONFIRMING FIT AND RANGE OF MOTION THE WOULD WAS CLOSED AND CASE WAS COMPLETED. EXPLANTED POLY WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16383 PS TIBIAL BEARING, SIZE 3, 13MM, VIT E PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH ARTHREX, INC. PS TIBIAL BEARING, SIZE 3, 13MM, VIT E 5791824 00888867232396

    Patients

    Seq Age Sex Outcome Treatment
    1 Other