BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2931210 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00344
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THIS EVENT IS A DUPLICATE OF MFR. REPORT # 2249697-2012-02506. WHEN AVAILABLE, INVESTIGATION RESULTS WILL BE SUBMITTED UNDER THIS MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    SURGEON REMOVED REJUVENATE LEFT HIP AND REVISED. PATIENT HAD ELEVATED COBALT.

    Description of Event or Problem · 1

    SURGEON REMOVED REJUVENATE LEFT HIP AND REVISED. PATIENT HAD ELEVATED COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37084 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MJK25A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention