BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10

    MDR report key: 2892145 · Received December 19, 2012

    Report

    Report Number
    2249697-2012-02753
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 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 PT HAD A REJUVENATE REVISION. BLOOD SERUM LEVEL WAS ELEVATED. THE PT'S COBALT LEVEL WAS 6.9 AND THE CHROMIUM LEVEL WAS 1.12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10 UNK JDI STRYKER ORTHOPAEDICS MAHWAH NA MJNEYA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R