BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY POST AUG TALAR SZ 3

    MDR report key: 3232721 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21493
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSN
    PMA / PMN Number
    PK920802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE TALAR COMPONENT PART AND LOT NUMBER COMBINATION; ONE ADDITIONAL REPORT FOR THE INSERT PART AND LOT NUMBER COMBINATION. HOWEVER, REVIEW OF THE AS400 SYSTEM SHOW THAT (B)(4) OTHER DEVICES FROM THE INSERT PART AND LOT HAVE BEEN DELIVERED AND/OR INVOICED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX D. NO ADDITIONAL INFORMATION OBTAINED. 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 OSTEOLYSIS, POLY WEAR, AND LOOSENING OF THE TALAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335858 AGILITY POST AUG TALAR SZ 3 TALAR ANKLE PROSTHESIS HSN 1818910 DEPUY ORTHOPAEDICS, INC. Z89BD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention