BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 34MM

    MDR report key: 2934986 · Received January 30, 2013

    Report

    Report Number
    0002249697-2013-00474
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. 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

    THIS MEDWATCH IS A DUPLICATE OF MF REPORT # 2249697-2012-02011, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO HIGH COBALT LEVELS AND PATIENT DISCOMFORT. RIGHT REJUVENATE HIP REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO HIGH COBALT LEVELS AND PATIENT DISCOMFORT. RIGHT REJUVENATE HIP REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40620 LRG TAP PRI MOD NCK 0DEG 34MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 34565001

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention