BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI

    MDR report key: 1864671 · Received October 5, 2010

    Report

    Report Number
    3004153240-2010-00030
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K043570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION PLANNED FOLLOWING A PATIENT FALL FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    REVISION PLANNED FOLLOWING A PATIENT FALL FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IUNI UNICONDYLAR KNEE REPAIR SYSTEM HSX CONFORMIS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R