BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER NEUT 62 OR 74ODX28ID

    MDR report key: 3771816 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17442
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    KWY
    PMA / PMN Number
    PK940743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249715 HYLAMER NEUT 62 OR 74ODX28ID HIP ACETABULAR INSERT/LINER KWY DEPUY ORTHOPAEDICS, INC.-1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention