BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PATELLA

    MDR report key: 2999385 · Received March 12, 2013

    Report

    Report Number
    1818910-2013-04216
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    September 5, 2012
    Report Date
    February 15, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** 02/15/2013 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION PATELLA BAJA WAS FOUND. THE FEMORAL AND PATELLA WERE ADDED TO THE COMPLAINT AND THE COMPLAINT WAS RE-OPENED. MEDICAL RECORDS AND X-RAYS WERE OBTAINED AND REVIEWED. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE FOR THE NEWLY ADDED PRODUCTS WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE PROVIDED INFORMATION. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING INFORMATION ON FEMORAL AND PATELLA. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES: ASEPTIC LOOSENING OF THE TIBIAL TRAY. **UPDATE** (B)(4) 2013 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION PATELLA BAJA WAS FOUND. THE FEMORAL AND PATELLA WERE ADDED TO THE COMPLAINT AND THE COMPLAINT WAS RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102826 UNKNOWN DEPUY PATELLA PATELLA HTG DEPUY WARSAW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention