BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY TIBIAL SHELL SZ 5 LT

    MDR report key: 2020049 · Received March 11, 2011

    Report

    Report Number
    1818910-2011-03986
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 9, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSN
    PMA / PMN Number
    MM 30-05
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE TIBIAL AND TALAR COMPONENT PART AND LOT NUMBER COMBINATIONS. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PART AND LOT CODE REQUIRED FOR THE INSERT WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION 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 INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED DUE TO TIBIAL AND TALAR COMPONENTS SUBSIDING. POLYWEAR DEBRIS AT TIBIAL LINER. OSTEOLYSIS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY TIBIAL SHELL SZ 5 LT 87HSN HSN DEPUY ORTHOPAEDICS, INC. NA V5DD91

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention