BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE NECK

    MDR report key: 2911045 · Received January 4, 2013

    Report

    Report Number
    9616680-2013-90028
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SURGEON REVISED PATIENT¿S RIGHT REJUVENATE HIP DUE TO PATIENT HAVING ELEVATED ION LEVELS AND A PSEUDO TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4202 UNKNOWN REJUVENATE NECK IMPLANT JDI STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention