BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NECK

    MDR report key: 2893482 · Received December 21, 2012

    Report

    Report Number
    9616680-2012-01483
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 3, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 WAS REPORTED THAT THE PATIENT IS CURRENTLY EXPERIENCING PAIN IN HIS HIP ESPECIALLY AFTER A LOT OF ACTIVITY. THE PATIENT STATES THAT HE HAS HAD PAIN SINCE (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NECK IMPLANT JDI STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other