BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH HINGE KNEE SYSTEM

    MDR report key: 1884440 · Received October 21, 2010

    Report

    Report Number
    9610726-2010-00377
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 7, 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
    US
    Reporter Occupation
    OTHER

    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: "PT WAS BEING REVISED DUE TO AN INFECTION; UPON REMOVING THE FEMORAL COMPONENT THE SURGEON NOTICED THAT THE DEVICE WAS BROKEN".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention