BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY TIBIAL INSERT SZ 4

    MDR report key: 1800813 · Received August 10, 2010

    Report

    Report Number
    1818910-2010-05576
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSN
    PMA / PMN Number
    K920802
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAM. A SEARCH OF THE WARSAW AND LEEDS COMPLAINT DATABASES FOR THE TALAR COMPONENT DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE. THE LOT NUMBER FOR THE INSERT WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS TALAR SUBSIDENCE. POLY WEAR WAS DISCOVERED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY TIBIAL INSERT SZ 4 87HSN HSN DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention