BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3844887 · Received June 3, 2014

    Report

    Report Number
    0002249697-2014-02037
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    April 5, 2013
    Report Date
    May 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN RIGHT STRYKER HIP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT LATER TIME IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT REPORTS PAIN AFTER RIGHT HIP REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324431 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other