BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR 10D LINER 28IDX58OD

    MDR report key: 3111714 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-17060
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC./REG. #1818910
    Product Code
    LPH
    PMA / PMN Number
    PK972596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    THE PATIENT WAS REVISED BECAUSE OF POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213448 DUR MAR 10D LINER 28IDX58OD HIP LINER LPH DEPUY ORTHOPAEDICS, INC./REG. #1818910 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention