BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2831043 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02161
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS: MFR # 9616680-2012-00978.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR REVISED PATIENT'S RIGHT HIP DUE TO ALTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 UNKNOWN MEH STRYKER ORTHOPAEDICS MAHWAH NA MJE1YD

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention