BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_LIM_PRODUCT

    MDR report key: 4140306 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03742
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN MRH FEMORAL COMPONENTS. THE SALES REP INDICATED THAT THE DEVICE AND MEDICAL RECORDS ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WOULD BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE DUE TO LOOSENING. AS PER SALES REP. DOCTOR STATED "PATIENT HAD CEMENT DISEASE ON THE FEMORAL SIDE." BUT CEMENT WAS IN TACK. SALES REP ALSO REPORTED, UPON EXTRACTION OF MRH FEMORAL COMPONENTS, THE LATERAL CONDYLE OF THE DEVICE HAD A FRACTURE IN THE METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619019 UNKNOWN_LIM_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R