BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY SIZE 6

    MDR report key: 6386975 · Received March 8, 2017

    Report

    Report Number
    1220246-2017-00049
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    January 25, 2017
    Report Date
    March 8, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    UDI-DI
    00888867106741
    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-TTTG AND LOT NUMBER 108761204 COMBINATION FOUND NO RELATED INFORMATION. DEVICE REPORTED DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT UNDERWENT A BILATERAL TKA PROCEDURE. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTG, LOT 108761204 ((B)(4)), AND BEARING IMPLANT, AR-503-BG08, LOT 654433 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX DEVICES: TIBIAL TRAY, AR-513-T7, LOT 10024600, BEARING IMPLANT, AR-513-BH18, LOT 113601405 AND STEM EXTENSION IMPLANT, AR-513-1450, LOT 10024600. PATIENT WAS A MALE, (B)(6). ADDITIONAL INFORMATION FROM PATIENT MEDICAL RECORDS: ON (B)(6) 2014: ASSESSMENT - ANKYLOSIS OF LEFT KNEE, EFFUSION OF LOWER LEG JOINT. PATIENT HAS SOME PLAY IN KNEE BUT NOT ENOUGH FOR SURGERY AT TIME OF NOTATION. ON (B)(6) 2015: PATIENT HAS LAXITY IN LEFT KNEE. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING. PALPATION OF THE LEFT KNEE DEMONSTRATED INFERIOR POLE PATELLA TENDERNESS, MEDIAL AND LATERAL JOINT LINE TENDERNESS AND PAIN WITH FLEXION. ON (B)(6) 2016: X-RAY FINDINGS LEFT KNEE, PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING, OR STRESS SHIELDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170399 IBALANCE TKA TIBIAL TRAY SIZE 6 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. 108761204 00888867106741

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other AR-503-BG08 IBALANCE TKA BEARING, LOT 654433