BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2910971 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90034
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 PATIENT HAD A RIGHT REJUVENATE IMPLANTED (B)(6) 2011 WAS REMOVED. PATIENT HAD ELEVATED COBALT LEVELS AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4122 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MJRD7T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R