BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 13

    MDR report key: 3375653 · Received September 30, 2013

    Report

    Report Number
    1818910-2013-28802
    Event Type
    Injury
    Date Received
    September 30, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 11, 2013
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S
    Product Code
    KWY
    PMA / PMN Number
    PK123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE CONDUCTED. NO ADDITIONAL INFORMATION WAS OBTAINED. 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. 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

    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

    PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED A BONE FRACTURE, DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492512 CORAIL2 STD SIZE 13 HIP STEM KWY 3003895575 DEPUY FRANCE S.A.S 5208483

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention