BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP REJUVENATE STEM

    MDR report key: 2911075 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90023
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    January 1, 2008
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 RECEIVED THE RECALL NOTIFICATION LETTER. THE PT STATES THAT HE HAS HAD HIS HIP ASPIRATED AND HE HAS FLUID ON HIS HIP. THE SURGEON IS RECOMMENDING REVISION SURGERY. PT STATES THAT HE IS CURRENTLY UNDERGOING CANCER TREATMENT AND CANNOT HAVE REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5158 UNKNOWN LEFT HIP REJUVENATE STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other