BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR CUP

    MDR report key: 3915668 · Received July 7, 2014

    Report

    Report Number
    1818910-2014-22745
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    March 18, 2014
    Report Date
    June 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    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 AND X-RAYS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. DISLOCATION IS CONFIRMED BUT NOT THE ROOT CAUSE. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION AND POLY WEAR. UPDATE: (B)(6) 2014 - DURING MEDICAL RECORD REVIEW IT WAS NOTED THAT THE CUP HAD MALPOSITIONED. CUP HAS BEEN ADDED TO THE COMPLAINT. COMPLAINT WAS UPDATED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393597 UNKNOWN DEPUY ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention