BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT - RIGHT STRYKER KNEE

    MDR report key: 2020057 · Received March 10, 2011

    Report

    Report Number
    2249697-2011-00291
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED, BUT NOT MADE AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT, "PATIENT CONTACTED STRYKER TO KNOW IF HER KNEE IS ON A RECALL. IN 2009 IMPLANT, RIGHT KNEE. TOTAL KNEE REPLACEMENT. DOES NOT HAVE PRODUCT NUMBER. IN A FOLLOW UP CALL WITH (B)(6), PATIENT STATED THAT SHE ALWAYS HAD PROBLEMS WITH HER KNEE AND DOCTOR TOLD HER IT TAKES TIME, BUT IT HAS BEEN TWO YEARS AND SHE STILL HAVE PROBLEMS WITH IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other