BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP IMPLANT

    MDR report key: 1063856 · Received June 19, 2008

    Report

    Report Number
    2249697-2008-00175
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFO AT THIS TIME TO DETERMINE IF A STRYER DEVICE CAUSED AN ADVERSE CONSEQUENCE FOR THE PT. THE INFO OF THIS PER WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. AS PER THE INFO RECEIVED, THE DEVICES ARE NOT AVAILABLE FOR THE TIME OF THE PER DUE TO THE ONGOING LITIGATION. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT SUFFERED INJURIES FROM A STRYKER HIP JOINT. NO FURTHER INFO IS AVAILABLE AT THIS TIME".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other