BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS POLY W/ 10 LIP 32 GR2

    MDR report key: 3900671 · Received June 27, 2014

    Report

    Report Number
    1818910-2014-22258
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 27, 2009
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JDI
    PMA / PMN Number
    PK861979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. THE INVESTIGATION HAS DETERMINED THE LINER PRODUCT CODE IS NOW OBSOLETE. IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. 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

    CLINICAL REPORT STATES THAT PATIENT WAS REVISED TO ADDRESS POLY WEAR AND DISLOCATION 22.2 YEARS AFTER PRIMARY THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377446 ACS POLY W/ 10 LIP 32 GR2 HIP ACETABULAR INSERT/LINER JDI DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention