BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 3911601 · Received June 27, 2014

    Report

    Report Number
    3004153240-2014-00081
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 5, 2014
    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

    SURGEON REPORTED THAT THE IMPLANT IS UNSTABLE. REVISION SURGERY IS PLANNED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE IMPLANT IS UNSTABLE. REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376346 IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM HSX CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention