BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2850823 · Received November 21, 2012

    Report

    Report Number
    2249697-2012-02440
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD ELEVATED COBALT LEVEL OF 18 AND WANTED THE REVISION. THEREFORE, THE SURGEON REVISED LEFT HIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R