BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIATHLON KNEE

    MDR report key: 2142420 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00929
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 18, 2010
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED: "PT CALLED TO REPORT PAIN. CAN HARDLY DO ANYTHING, HER KNEE GIVES OUT ON HER, HAS SWELLING. PT SAYS SHE IS OBTAINING MEDICAL RECORDS. SAYS SHE IS SCHEDULED FOR A REVISION ON (B)(6) 2011.".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other