BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUST AGILITY FLANGE TALAR SZ3

    MDR report key: 2034054 · Received March 24, 2011

    Report

    Report Number
    1818910-2011-04941
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    DEPUY ORHTOPAEDICS, 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 DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. THE PRE AND POST-OP X-RAYS ARE NOT AVAILABLE FOR EVALUATION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ALL THREE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFORMATION STATES THE IMPLANTS HAVE BEEN IMPLANTED FOR TWELVE YEARS. 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

    PT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL SHELL, TALAR SUBSIDENCE, POLY WEAR OF THE TIBIAL LINER, AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUST AGILITY FLANGE TALAR SZ3 87HSN HSN DEPUY ORHTOPAEDICS, INC. NA S68AD1004

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention