BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 2973489 · Received February 14, 2013

    Report

    Report Number
    3004153240-2013-00017
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CONFORMIS, INC.
    Product Code
    HSX
    PMA / PMN Number
    K111916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    PT WITH A UNICONDYLAR KNEE IMPLANT EXPERIENCED A FALL AND HAS A FLEXION CONTRACTURE. SURGICAL INTERVENTION IS PLANNED TO EXAMINE THE KNEE. POLY INSERTS MAY BE REPLACED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66234 IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM HSX CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention