BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT LEFT KNEE REPLACEMENT

    MDR report key: 2062723 · Received April 13, 2011

    Report

    Report Number
    2249697-2011-00443
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT TO STRYKER THAT, "2007 KNEE REPLACEMENT, HAVING A LOT OF PAIN, KNEE IS LOOSE. DR. DID A SECOND KNEE REPLACEMENT, (B)(6) 2008. (DIFFERENT DOCTOR THAN THE FIRST DOCTOR.) STILL HAVING PAIN. WANTS TO KNOW WHY HE IS HAVING SO MUCH PAIN. CAN SOMEONE CALL HIM BACK? CANNOT PUT WEIGHT ON IT. WANTS SOME ANSWERS AS TO WHY IT HURTS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other