BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CR INSERT

    MDR report key: 2161201 · Received July 8, 2011

    Report

    Report Number
    2249697-2011-01024
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD MULTIPLE FALLS REQUIRING THE SURGEON TO REVISE THE KNEE. THE SURGEON COMMENTED THAT THE CR INSERT LOOKED PITTED AND WANTED IT INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CR INSERT IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention