BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 4102616 · Received September 11, 2014

    Report

    Report Number
    3004153240-2014-00125
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K131019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN ARTHROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014, LOOSENING OF THE POLY INSERT WAS IDENTIFIED. REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014, LOOSENING OF THE POLY INSERT WAS IDENTIFIED. REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562454 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention