BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - KNEE

    MDR report key: 1861941 · Received October 5, 2010

    Report

    Report Number
    2249697-2010-01317
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT 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 DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "(B)(6) STATED THAT SHE HAD A KNEE REPLACEMENT IN (B)(6) 2003 AND HAS PAIN SINCE. SHE SAW THAT STRYKER HAD A KNEE RECALL ON MED ALERT AND WANTED INFO. I TOLD HER, WE HAD A NUMBER OF DIFFERENT MODELS OF KNEE REPLACEMENT AND ASKED IF SHE KNEW WHICH MODEL. SHE DOESN'T. I TOLD HER WE WOULD OPEN A PER SO SHE COULD RELEASE HER MEDICAL RECORDS TO US SO WE CAN IDENTIFY IF HER REPLACEMENT WAS PART OF A RECALL."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other