BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 28X61MM

    MDR report key: 2850960 · Received November 20, 2012

    Report

    Report Number
    2249697-2012-02425
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNK C-TAPER HEAD CERAMIC WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE LIMITED INFO PROVIDED. AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING LOT CODE OF THE REPORTED DEVICE, X-RAYS AND MEDICAL RECORDS) WAS NOT MADE AVAILABLE EITHER. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT SCHEDULED FOR A REVISION OF LEFT HIP FROM APPROX 10 YEARS AGO BECAUSE OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UHR BIPOLAR 28X61MM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention