BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3120438 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01700
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN TRITANIUM CUP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SHELL MALPOSITION INVOLVING AN UNKNOWN SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE REPORTED DEVICE LOT CODE WAS NOT PROVIDED. A REVIEW OF THE COMPLAINT DATABASES COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NO PROPERLY IDENTIFIED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT HIP WAS REVISED. TRITANIUM CUP AND MDM LINER REVISED DUE TO CUP POSITION AND PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT HIP WAS REVISED. TRITANIUM CUP AND MDM LINER REVISED DUE TO CUP POSITION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222473 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention