BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3203175 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02216
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN INSERT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. 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.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS THE DEVICE WAS NOT RETURNED AND MEDICAL RECORDS WERE NOT RECEIVED FOR EVALUATION. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE CATALOG NUMBER AND LOT NUMBER OF THE REPORTED DEVICE WAS NOT PROVIDED AND THE DEVICE WAS NOT FULLY IDENTIFIED. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE CATALOG NUMBER AND LOT NUMBER OF THE REPORTED DEVICE WAS NOT PROVIDED AND THE DEVICE WAS NOT FULLY IDENTIFIED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICE, MEDICAL OR PATIENT INFORMATION WAS PROVIDED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF A PCA HIP. REVISED BECAUSE OF A WORN POLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF A PCA HIP. REVISED BECAUSE OF A WORN POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302068 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention