BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2831083 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02196
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    March 18, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. DEVICE INFORMATION HAS NOT BEEN PROVIDED AT THIS TIME. INFORMATION RECEIVED FROM THE PT INDICATED THAT REPORTED DEVICE MAY BE EITHER REJUVENATE OR ABGII. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. 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: PT IS EXPERIENCING EXTREME PAIN, NUMBNESS, AND MUSCLE SPASMS. PT IS ALSO REPORTING THAT HE IS EXPERIENCING STIFFNESS AND SORENESS. PT STATES THAT THE PAIN STARTED THREE MONTHS AGO AND IT WAS LOCALIZED BUT HAS SINCE INCREASED. PT STATES THAT DOCTOR WANTS MRI TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LEFT HIP IMPLANT JDI STRYKER ORHTOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other