BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT LS INSERT MED 8MM

    MDR report key: 3056382 · Received April 12, 2013

    Report

    Report Number
    0002249697-2013-01278
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K921640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING JOINT INSTABILITY INVOLVING A KINEMAX TIBIAL INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO INSTABILITY. REPLACED WITH AN 12MM INSERT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO INSTABILITY. REPLACED WITH AN 12MM INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159408 KX+ DURAT LS INSERT MED 8MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH TCP93341

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention