BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +8.5

    MDR report key: 6550765 · Received May 6, 2017

    Report

    Report Number
    1818910-2017-17679
    Event Type
    Injury
    Date Received
    May 6, 2017
    Date of Event
    September 13, 2014
    Report Date
    June 8, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 06/08/2017. UPON REVIEW OF THE MEDICAL RECORDS, THE CLINICAL DER STATES THAT THE AE WAS NOT DEVICE RELATED AND THE MEDICAL RECORDS CONFIRM THAT THE REVISION WAS DUE TO SOFT TISSUE LAXITY, WHICH IS NON-REPORTABLE, THEREFORE THIS MDR WILL BE CHANGED TO MDR NO. THIS REPORT, 1818910 - 2017 - 17679, IS BEING REJECTED. DEPUY 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

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    UPDATE 04/04/2017 MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS INSTABILITY, WHICH WAS FOUND TO BE CONSISTENT WITH LAXITY OF THE SOFT TISSUE. IT WAS ALSO NOTED THAT THE PATIENT HAD STOOD UP AND TWISTED, WHICH IS AGAINST HIP PROTOCOL. COMPLAINT UPDATED 06/08/2017.

    Description of Event or Problem · 1

    CLINICAL DER STATES THAT THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331349 DELTA CER HEAD 12/14 36MM +8.5 ARTICUL/EZE TOTAL HIP BALL(C D ) LZO DEPUY IRELAND 9616671 7820897

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention