BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE HIP

    MDR report key: 2832999 · Received October 30, 2012

    Report

    Report Number
    2249697-2012-02124
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    June 1, 2011
    Report Date
    October 5, 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
    AR, 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. ADD¿L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD¿L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: PATIENT COMPLAINS OF HIP, THIGH, AND GROIN PAIN SINCE THE SURGERY. PT IS CALLING TO FILE A CLAIM AS ADVISED BY HER SURGEON FOR THE EVALUATIONS THAT SHE WILL REQUIRE AS PART OF THE RECALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other