BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - HIM SYSTEM

    MDR report key: 2062746 · Received April 13, 2011

    Report

    Report Number
    2249697-2011-00454
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    December 3, 2007
    Report Date
    March 17, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR A PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY, THE PATIENT IS SUFFERING SIGNIFICANT PAIN AS A RESULT OF THE IMPLANTATION OF A HIP SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R