BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781206 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01671
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 1, 2010
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN LINER . AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. 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 PATIENTS RIGHT HIP WAS REVISED DUE TO DISLOCATION WHICH WAS REVEALED TO THE SALES REP AT THE TIME OF THE PATIENTS' 2ND REVISION ON (B)(6) 2014. THE SALES REP ASKED THE REVISION SURGEON IF HE HAD ANY FURTHER INFORMATION REGARDING THE FIRST REVISION. HE STATED THAT THE REVISION OF THE PRIMARY WAS DONE OUT OF THEIR AREA AND HE DOES NOT HAVE ADDITIONAL INFORMATION. NO FURTHER INFORMATION WILL BE MADE AVAILABLE TO THE SALES REP FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260775 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R