BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NECK

    MDR report key: 2871943 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01333
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    June 1, 2011
    Report Date
    November 15, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, PT IS EXPERIENCING PAIN IN THERE HIP AREA. THE PAIN STARTED THREE TO SIX MONTHS POST SURGERY. AT THE TWELVE MONTH CHECK UP, PT HAD MRI AND SURGEON FOUND LARGE PSEUDO TUMOR. PT ALSO HAD BLOOD WORK DONE AND ELEVATED LEVELS OF METAL WERE FOUND IN HIS SYSTEM. PT ALSO HAD FLUID ASPIRATED FROM HIS HIP. PT HAD REVISION SURGERY ON AUGUST 3, 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R