BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT HIP NECK

    MDR report key: 2896227 · Received December 28, 2012

    Report

    Report Number
    9616680-2012-01525
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    September 1, 2010
    Report Date
    December 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 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 PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED RECALL NOTIFICATION. PT IS NOT EXPERIENCING PAIN. PT COMPLETED BLOOD TEST AND X-RAYS. BLOOD TEST SHOWED ELEVATED METAL LEVELS. PT IS SCHEDULED FOR AN MRI.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other