BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP REJUVENATE STEM

    MDR report key: 2911056 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90021
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    September 14, 2011
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 RECALL NOTIFICATION LETTER FROM SURGEON. THE PT IS EXPERIENCING PAIN IN HIS RIGHT THIGH. THE PT STATES THAT HIS COBALT LEVEL IS SLIGHTLY ELEVATED AND HE IS HAVING AN MRI IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5181 UNKNOWN RIGHT HIP REJUVENATE STEM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other