BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY SIZE 2

    MDR report key: 5466993 · Received February 29, 2016

    Report

    Report Number
    1220246-2016-00072
    Event Type
    Injury
    Date Received
    February 29, 2016
    Date of Event
    November 9, 2015
    Report Date
    February 4, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    PMA / PMN Number
    K081127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO ARTHREX'S FOLLOW-UP REQUESTS. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION RECEIVED REGARDING THE EVENT IS NOT SUFFICIENT TO DETERMINE THE CAUSE OF THE EVENT. A DHR REVIEW FOR THIS CATALOG NUMBER, AR-503-TTTC AND LOT NUMBER, 108761331 COMBINATION FOUND NO RELATED INFORMATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TKA ON (B)(6) 2014. ON (B)(6) 2015, PATIENT HAD A RIGHT TKA REVISION SURGERY DUE TO TIBIAL LOOSENING. DURING THE REVISION THE TIBIAL TRAY AR-503-TTTC (LOT 108761331) WAS EXPLANTED ALONG WITH THE FOLLOWING ORIGINAL IMPLANTS: FEMORAL IMPLANT AR-503-PSLC (LOT 013409), TIBIAL BEARING IMPLANT AR-503-BC09 (LOT 113601232), PATELLA IMPLANT AR-504-PSB8 (LOT 113601235). PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCTS. EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY AND ARE NO LONGER AVAILABLE TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124956 IBALANCE TKA TIBIAL TRAY SIZE 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. 108761331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AR-503-BC-09, TKA BEARING, LOT 113601232