BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DURALOC ACETABULAR LINER

    MDR report key: 3884857 · Received June 19, 2014

    Report

    Report Number
    1818910-2014-21547
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    ADDITIONAL NARRATIVE: 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

    PATIENT COMPLAINED OF PAIN. ON XRAY EXAMINATION, ACETABULAR INSERT WAS SEEN TO BE WORN SUPERIORLY. SURGERY WAS SCHEDULED. SURGEON REMOVED 28MM 10DEGREE INSERT AND 28MM CERAMIC HEAD. REPLACED WITH FRESH LOCKING RING, 36MM AND +4 INSERT, AND 36 +0 FEMORAL HEAD. UPDATE REC'D 07/01/2014 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT'S FEMORAL HEAD WAS RIDING HIGH DUE TO THE POLY WEAR OF THE LINER. UPON REVISION THE LOCKING RING WAS EXCHANGED FOR PRECAUTIONARY MEASURES ALTHOUGH IT APPEARED TO BE INTACT. UPDATE RECEIVED 9/10/14. MEDICAL RECORDS PROVIDED INDICATE THAT THE ACETABULAR CUP WAS MALPOSITIONED. A CUP IS BEING REPORTED TO ADDRESS THE MALPOSITION. DOI (B)(6) 1999 - DOR (B)(6) 2014 (RIGHT HIP). 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. WITH THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED AS THE MALPOSITIONED CUP COULD HAVE CONTRIBUTED TO ACCELERATED POLYETHYLENE WEAR RATES. 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

    PATIENT COMPLAINED OF PAIN. ON XRAY EXAMINATION, ACETABULAR INSERT WAS SEEN TO BE WORN SUPERIORLY. SURGERY WAS SCHEDULED. SURGEON REMOVED 28MM 10 DEGREES INSERT AND 28MM CERAMIC HEAD. REPLACED WITH FRESH LOCKING RING, 36MM AND +4 INSERT, AND 36 +0 FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360019 UNKNOWN DEPUY DURALOC ACETABULAR LINER HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention