BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 2221525 · Received August 11, 2011

    Report

    Report Number
    2249697-2011-01185
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICES LISTED IN THIS REPORT: DESCRIPTION: UNK LINER (CATALOG # AND LOT# UNK), UNK CUP (CATALOG # AND LOT # UNK), UNK SCREW (CATALOG # AND LOT # UNK). IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. THE DEVICES ARE NOT BEING RETURNED TO THE MFR AS THEY WERE GIVEN TO THE PT. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HAD AVASCULAR NECROSIS APPROX 25 YRS AGO AS WELL AS NON HODGKIN'S LYMPHOMA. PT BEGAN HAVING PAIN AND THE SURGEON DECIDED TO REVISE WITH NEW HEAD, CUP, LINER AND SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN HEAD IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R