BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY LP TIBIAL SZ2 RT

    MDR report key: 1170007 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-03833
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSN
    PMA / PMN Number
    K053569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ALL THREE REPORTED PART AND LOT NUMBER COMBINATIONS. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, THE INFECTION MAY BE A CONTRIBUTING FACTOR OF THE LOOSENING. PROVIDED INFO MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCTS AND/OR 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

    THE PATIENT WAS REVISED BECAUSE OF INJECTION. THE TALAR AND TIBIAL COMPONENTS WERE FOUND LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY LP TIBIAL SZ2 RT 87HSN HSN DEPUY ORTHOPAEDICS, INC. NA A2PGJ1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention