BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 6046505 · Received October 21, 2016

    Report

    Report Number
    3004153240-2016-00214
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    HSX
    PMA / PMN Number
    K111916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700387 IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM HSX CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention