BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 9

    MDR report key: 5998319 · Received October 4, 2016

    Report

    Report Number
    1818910-2016-28737
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWL
    PMA / PMN Number
    K123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. (B)(4). 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 PATIENT WAS REVISED TO ADDRESS A PERIPROSTHETIC BONE FRACTURE. THE REASON FOR THE BONE FRACTURE IS NOT KNOWN. THE TOP OF THE FEMUR WAS BROKEN OFF. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS A PERIPROSTHETIC BONE FRACTURE. THE REASON FOR THE BONE FRACTURE IS NOT KNOWN. THE TOP OF THE FEMUR WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648708 CORAIL2 STD SIZE 9 HIP FEMORAL STEM/SLEEVE KWL DEPUY FRANCE SAS 3003895575 3373583

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention