BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUS AG X WIDENED TALAR SIZE 6

    MDR report key: 3113828 · Received May 15, 2013

    Report

    Report Number
    1818910-2013-17141
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSN
    PMA / PMN Number
    PK920802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND ONE ADDITIONAL REPORT FOR THIS PART AND LOT NUMBER COMBINATION BUT WAS NOT FOR PAIN OR LOOSENING. THE PRODUCTS HAVE BEEN IMPLANTED FOR OVER TEN YEARS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX C. TERRITORY OFFICE COMMUNICATED NO ADDITIONAL INFORMATION IS AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. LOOSENING OF THE TALAR COMPONENT WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215275 CUS AG X WIDENED TALAR SIZE 6 ANKLE PROSTHESIS HSN 1818910 DEPUY ORTHOPAEDICS, INC. WB2JP1001

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention