BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3940551 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02748
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    November 23, 2013
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT INVOLVED A COMPETITOR'S DEVICE.

    Description of Event or Problem · 1

    PATIENT REPORTS EXTREME PAIN AFTER PRIMARY BILATERAL SURGERIES. PATIENT STATES SHE HAS SEVERE SUBLUXATION ON BOTH KNEES. PATIENT REPORTS SHE NEEDS FULL KNEE REPLACEMENT REVISIONS ON BOTH KNEES. PATIENT HAS REVISION OF LEFT KNEE SCHEDULED ON (B)(6). DR. (B)(6) WILL DO THE REVISION SURGERIES AND THE RIGHT KNEE WILL BE A FEW MONTHS AFTER.

    Description of Event or Problem · 1

    PATIENT REPORTS EXTREME PAIN AFTER PRIMARY BILATERAL SURGERIES. PATIENT STATES SHE HAS SEVERE SUBLUXATION ON BOTH KNEES. PATIENT REPORTS SHE NEEDS FULL KNEE REPLACEMENT REVISIONS ON BOTH KNEES. PATIENT HAS REVISION OF LEFT KNEE SCHEDULED ON (B)(6). DR. (B)(6) WILL DO THE REVISION SURGERIES AND THE RIGHT KNEE WILL BE A FEW MONTHS AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419474 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other