BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN KNEE PRODUCT

    MDR report key: 1030832 · Received April 17, 2008

    Report

    Report Number
    2249697-2008-00094
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    June 19, 2007
    Report Date
    February 4, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE HAVE NOT YET RECEIVED ADD'L INFO ABOUT THIS EVENT, IT HAS BEEN DECIDED TO REPORT UNDER MDR SINCE THE PT HAS REPORTED PAIN AND IS WEARING A BRACE, INDICATING IMPAIRMENT. SIMILAR EVENTS HAVE RESULTED IN REVISION AND WERE REPORTED AS SERIOUS INJURIES. DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT COMPLAINING OF A LOT OF PAIN AND KNEE SWELLING. PT IS CURRENTLY IN A BRACE AND UNDER DOCTOR CARE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other