BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2896129 · Received December 27, 2012

    Report

    Report Number
    2249697-2012-02794
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER ORTHPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, DR. (B)(6) STATES PT PRESENTED WITH INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 IMPLANT JDI STRYKER ORTHPAEDICS MAHWAH NA MKKREX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention