BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY LP TIBIAL INSERT SZ6

    MDR report key: 2172613 · Received July 19, 2011

    Report

    Report Number
    1818910-2011-13374
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 4, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSN
    PMA / PMN Number
    K053569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR FOR REPORTS BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFO STATES, THE TIBIAL SHELL WAS MISALIGNED. 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. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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 REVISED FOR MALALIGNMENT OF TIBIAL SHELL, POLYETHYLENE WEAR NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY LP TIBIAL INSERT SZ6 87HSN HSN DEPUY ORTHOPAEDICS, INC. NA A31GR1000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention