BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3010139 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01022
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. THE EVENT WAS NOT CONFIRMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN PRECISION STRATA HIP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF CHRONIC HIP PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF CHRONIC HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113925 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention