BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE SYSTEM

    MDR report key: 2182476 · Received July 19, 2011

    Report

    Report Number
    2249697-2011-01086
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    August 29, 2008
    Report Date
    June 29, 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
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LETTER FROM THE PATIENT THAT, "HE HAD A TOTAL KNEE REPLACEMENT SURGERY IN (B)(6) OF 2008 ON HIS RIGHT KNEE AND IT NEVER STOPPED SWELLING. IN 2010, HIS KNEE CAP SLIPPED TO THE SIDE. SINCE THEN HIS KNEE HURTS WHEN HE SITS AND STANDS. PATIENT WANTS TO KNOW IF HIS IMPLANT WAS PART OF A RECALL."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other