BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 1147044 · Received August 28, 2008

    Report

    Report Number
    2249697-2008-00234
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED / ALLEGED BY THE PATIENT THAT, "THEY SUFFERED INJURIES RESULTING FROM AN UNKNOWN DEFECTIVE HIP PRODUCT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other