BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE STEM

    MDR report key: 2896041 · Received December 27, 2012

    Report

    Report Number
    2249697-2012-02797
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PATIENT HAD A REVISION SURGERY OF HIP STEM DUE TO PAIN IN LEFT LEG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R