BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP FRACTURE STEM #1

    MDR report key: 2162167 · Received July 7, 2011

    Report

    Report Number
    9616680-2011-00460
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWL
    PMA / PMN Number
    K883179
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WAS WALKING WHEN HER HIP GAVE WAY. THE FEMORAL COMPONENT FRACTURED BELOW THE FENESTRATION IN THE STEM. STEM REPLACED WITH A CEMENTED LONG STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP FRACTURE STEM #1 IMPLANT KWL STRYKER ORTHOPAEDICS CORK NA DBECA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R