BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE HIP DEVICE

    MDR report key: 2801207 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01923
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AS PER DR (B)(6) OFFICE, THIS PATIENT IS EXPERIENCING DIFFICULTIES WITH THEIR HIP IMPLANT AND HAS HAD BLOOD TESTS AND MRI.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other