BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NECK

    MDR report key: 2901616 · Received January 3, 2013

    Report

    Report Number
    9616680-2013-90003
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THROUGH A FILING OF A LAWSUIT THAT THE PT BEGAN EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT IN THE AREA OF THE DEVICE. IT IS ALLEGED THAT FURTHER DIAGNOSTIC WORKUP REVEALED ONE OF MORE OF THE FOLLOWING FINDINGS: THE PRESENCE OF PSEUDO TUMOR FORMATION, THE EXISTENCE OF A SIGNIFICANT FLUID COLLECTION ABOUT THE HIP PROSTHESIS, AND/OR BLOOD TESTING INDICATING THE PRESENCE OF HEAVY METAL ION CONCENTRATION. IT IS FURTHER ALLEGED THAT BASED ON THESE FINDINGS AND IN LIGHT OF WORSENING SYMPTOMS, THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2845 UNKNOWN NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention