BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER HIP

    MDR report key: 2202442 · Received August 5, 2011

    Report

    Report Number
    2249697-2011-01170
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    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

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF IT BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD REVISION SURGERY. SHE WAS TOLD RECENTLY FROM A SURGEON THAT SHE HAS HAD BONE GRAFTS AND SHOULD HAVE BEEN PUT ON CRUTCHES AFTER THE PROCEDURE BUT WAS NOT. SHE IS AFRAID THAT SHE IS LOSING MORE AND MORE BONE WITH EACH REVISION AND CONCERNED THAT HER LATEST HIP, WHICH IS A MONTH OLD, MAY FAIL AGAIN."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R