BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT NECK

    MDR report key: 2872165 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01312
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    April 2, 2012
    Report Date
    November 14, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER, BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A RECALL NOTIFICATION LETTER FROM HER SURGEON. THE PATIENT STATES SHE BEGAN EXPERIENCING A SHARP PAIN IN THE HIP AND THIGH IN (B)(6) 2012. SHE COULD FEEL A SEPARATION IN THE MUSCLE IN THE FRONT PART OF THE THIGH AND THE INTENSE PAIN CAUSED HER TO WALK WITH A PRONOUNCED LIMP. IT IS VERY PAINFUL TO WALK OR STAND FOR A LONG PERIOD. THE HIP WAS WARM TO THE TOUCH, HAD A BURNING SENSATION AND APPEARED TO BE VISIBLY SUNKEN IN AT THE IMPLANT SITE. A PHYSICAL EVALUATION, MRI, BLOOD TEST, AND X-RAYS WERE COMPLETED. BLOOD LABS INDICATED SLIGHTLY ELEVATED METAL LEVELS AND THE MRI SHOWED FLUID AROUND THE IMPLANT. THE PATIENT HAS REVISION (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R