BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFORMA

    MDR report key: 2070966 · Received April 20, 2011

    Report

    Report Number
    3004153240-2011-00020
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 21, 2011
    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

    REVISION PLANNED FOR PATIENT WITH A KNEE INTERPOSITIONAL DEVICE. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. REVISION IS DUE TO PAIN CAUSED BY FEMOROPATELLAR ARTHRITIS UNRELATED TO THE IFORMA DEVICE.

    Description of Event or Problem · 1

    REVISION PLANNED FOR PATIENT WITH A KNEE INTERPOSITIONAL DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R