BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER NEUT 58 OR 70ODX28ID

    MDR report key: 3925422 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23098
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    JDL
    PMA / PMN Number
    PK900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A DHR REVIEW OR LOT SPECIFIC DATABASE SEARCH WAS NOT POSSIBLE FOR THE ADDITIONAL PRODUCT ASSOCIATED WITH THIS REPORT AS LOT CODE(S) WAS NOT PROVIDED. PER THE INITIAL REPORTING; THERE IS NO ADDITIONAL INFORMATION INFORMATION AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A 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

    THE PATIENT WAS REVISED BECAUSE OF INFECTION AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403164 HYLAMER NEUT 58 OR 70ODX28ID HIP ACETABULAR INSERT/LINER JDL DEPUY ORTHOPAEDICS, INC.-1818910 828090

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention