BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3984391 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03044
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    October 18, 2007
    Report Date
    July 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT 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

    AS PER THE OP REPORT RECEIVED, THE REPORTED DEVICE IS NOT A STRYKER PRODUCT. IT IS REPORTEDLY EXACTECH PRODUCTS. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE ON (B)(6) 2007 AND CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT. PATIENT CANNOT SIT FOR LONG PERIODS OF TIME; HER KNEE IS SWOLLEN AND HAS DIFFICULTY WALKING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE ON (B)(6) 2007 AND CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT. PATIENT CANNOT SIT FOR LONG PERIODS OF TIME; HER KNEE IS SWOLLEN AND HAS DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460718 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other