BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT REJUVENATE NECK

    MDR report key: 2885244 · Received December 18, 2012

    Report

    Report Number
    9616680-2012-01442
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    July 21, 2011
    Report Date
    November 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING PAIN IN (B)(6) 2012. THE PATIENT REPORTS SLIGHT PAIN ON THE OUTSIDE OF THE LEFT HIP AT THE INCISION SIGHT. THE PATIENT ALSO REPORTS CONSTANT, INTENSE GROIN PAIN. THE PATIENT STATES THEY CANNOT STAND FOR SIGNIFICANT PERIODS OF TIME AND MUST REGULARLY USE A CANE TO MAINTAIN STABILITY. THE PATIENT HAD AN MRI AND TWO HIP ASPIRATIONS. BLOOD TEST RECORD COBALT LEVELS OF 4.7 AND 5.1 RESPECTIVELY OVER A TWO MONTH PERIOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR