BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFORMA

    MDR report key: 1822772 · Received August 30, 2010

    Report

    Report Number
    3004153240-2010-00024
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    March 1, 2007
    Report Date
    August 2, 2010
    Manufacturer
    CONFORMIS
    Product Code
    HSH
    PMA / PMN Number
    K033242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL REVISION FOR PATIENT WITH A KNEE INTERPOSITIONAL DEVICE. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    POTENTIAL REVISION FOR PATIENT WITH A KNEE INTERPOSITIONAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IFORMA KNEE INTERPOSITIONAL DEVICE HSH CONFORMIS 1060-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R