BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SCREW

    MDR report key: 4090013 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28023
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    April 6, 2010
    Report Date
    March 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    MEDICAL RECORDS RECEIVED. REVISION OPERATIVE NOTES INDICATE INFECTION. ALL PRODUCTS ARE BEING REPORTED. OPERATIVE NOTE MENTIONED MULTIPLE SCREWS; HOWEVER, WE ARE UNAWARE OF THE QUANTITY. A STICKER SHEET WAS NOT PROVIDED AND AN INVOICE COULD NOT BE LOCATED. THEREFORE, WE ARE REPORTING TWO SCREWS. IT SHOULD BE NOTED, THESE RECORDS WERE RECEIVED THROUGH A PPD INFLUX. THERE IS AN ADDITIONAL EXISTING LEGAL COMPLAINT FOR THIS PATIENT. THIS COMPLAINT IS NOW LEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569662 UNKNOWN DEPUY SCREW HIP OTHER IMPLANT SCREW HWC DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention