BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 62 OR 74ODX28ID

    MDR report key: 3771184 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17441
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. IT IS KNOWN THAT THIS PRODUCT IS NOW OBSOLETE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITHOUT DEVICE EXAMINATION. HOWEVER ALTHOUGH NOT RETURNED, 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

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249660 HYLAMER 10D 62 OR 74ODX28ID HIP ACETABULAR LINER JDL DEPUY ORTHOPAEDICS, INC. 542170

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention