BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DALL MILES VIT 1.6MM CABLE

    MDR report key: 2161163 · Received July 8, 2011

    Report

    Report Number
    9616680-2011-00465
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KTT
    PMA / PMN Number
    K872224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS FOUND THAT THE CABLE WAS BROKEN WHEN THE PATIENT COMPLAINED THE PAIN AND WAS X-RAYED. THE BROKEN CABLE WAS IMPLANTED ABOUT 5 YEARS AGO FOR THA REVISION IN ANOTHER HOSPITAL (B)(6) AND WE CANNOT SPECIFY THE LOT NUMBER. IF THE PATIENT'S PAIN WILL CONTINUE THE BROKEN CABLE WILL BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALL MILES VIT 1.6MM CABLE IMPLANT KTT STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention