BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP STEM

    MDR report key: 2910970 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90033
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    September 28, 2011
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADD¿L 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 PATIENT IS EXPERIENCING DISCOMFORT IN THE HIP. RECENT BLOOD TEST AND MRI SHOW ELEVATED METAL LEVELS AND FLUID ON THE HIP. THE PATIENT REQUIRES REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5306 UNKNOWN RIGHT HIP STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other