BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON TOTAL RIGHT KNEE REPLACEMENT

    MDR report key: 1964056 · Received January 11, 2011

    Report

    Report Number
    2249697-2011-00027
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "HIS KNEE SWELLS, IT LOCKS WHEN HE TRIES TO BEND IT. WHEN HE FALLS ASLEEP HE SLEEPS WITH HIS LEG STRAIGHT WHEN HE GOES TO GET UP IT BENDS, LOCKS AND POPS. HE IS UNDER A LOT OF PAIN AND SOMETIMES SCREAMS FROM THE PAIN HE IS FEELING. HE WANTS THIS TO BE BETTER AND HE WOULD LIKE FOR SOMEONE TO HELP HIM. HE CAN'T EVEN EXERCISE OR LIVE A NORMAL ACTIVE LIFE. HE HAS GONE ON DISABILITY AND CLAIM BANKRUPTCY BECAUSE OF HIS KNEE. DOCTOR TOLD HIM THAT HIS KNEE REPLACEMENT WAS GOING TO BE LIFE CHANGING FOR THE BETTER AND THIS WAS NOT WHAT HE EXPECTED. HE IS GOING TO SEE HIS DOCTOR FOR MORE X-RAYS IN (B)(6) 2011."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON TOTAL RIGHT KNEE REPLACEMENT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other