BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL

    MDR report key: 2211379 · Received August 8, 2011

    Report

    Report Number
    3004153240-2011-00032
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 23, 2011
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K103117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT EXPERIENCED ALLERGIC REACTION FOLLOWING TKR SURGERY. CAUSE OF ALLERGIC REACTION IS UNK. THE ITOTAL INSTRUCTIONS FOR USE LISTS METAL SENSITIVITY AS A CONTRAINDICATION AND CAUTIONS OF ALLERGIC REACTION TO IMPLANT MATERIALS INCLUDING BONE CEMENT.

    Description of Event or Problem · 1

    PT EXPERIENCED ALLERGIC REACTION FOLLOWING TKR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITOTAL TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other