BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP

    MDR report key: 2831121 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02205
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    June 1, 2011
    Report Date
    October 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. DEVICE INFO HAS NOT BEEN PROVIDED AT THIS TIME. INFO RECEIVED FROM THE PT INDICATED THAT REPORTED DEVICE MAY BE EITHER REJUVENATE OR ABGII. ADD¿L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADD¿L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WIFE OF PATIENT IS EXPERIENCING PAIN AND CAN¿T LIFT LEG. PT HAS METAL IN BLOOD. PT HAS REVISION SURGERY SET FOR (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other