BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 3111856 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-17063
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. PER THE INITIAL REPORTING, THE SURGEON WILL NOT RELEASE ANY ADDITIONAL INFORMATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE, HOWEVER, IN THE LEFT HIP IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH COMPETITOR MANUFACTURED PRODUCTS. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    PATIENT'S LEFT HIP WAS REVISED TO ADDRESS DISLOCATION. ON THIS SIDE, THE HEAD WAS DEPUY PRODUCT; THE LINER WAS COMPETITOR PRODUCT. PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS LEG LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212695 UNKNOWN DEPUY FEMORAL HEAD FEMORAL HEAD KWY 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention