BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PRODUCT - RIGHT KNEE

    MDR report key: 1874091 · Received October 14, 2010

    Report

    Report Number
    9610726-2010-00360
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    November 15, 2006
    Report Date
    September 27, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IN (B)(6) 2006 PT RECEIVED THE INITIAL RIGHT STRYKER KNEE. FIRST REVISION WAS (B)(6) 2006 DUE TO PT BEING "KNOCKED KNEED". THIS MADE IT BETTER BUT STILL REMAINED A PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PRODUCT - RIGHT KNEE IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention