BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES I TIBIAL BEARING INSERT

    MDR report key: 1932951 · Received December 15, 2010

    Report

    Report Number
    2249697-2010-01748
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSX
    PMA / PMN Number
    K862837
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DUE TO HOSPITAL POLICY. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) 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 PRESENTED WITH KNEE PAIN IN THE OFFICE. REVISION WAS DUE TO POSSIBLE POLY EXCHANGE OR POSSIBLE FULL COMPONENT EXCHANGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES I TIBIAL BEARING INSERT IMPLANT HSX STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention