BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2901628 · Received January 3, 2013

    Report

    Report Number
    2249697-2013-90004
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SURGEON REVISED PATIENT'S RIGHT REJUVENATE HIP DUE TO PAIN AND MRI SHOWED PSEUDO TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA 9LKMED

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R