BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 15

    MDR report key: 4192527 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30413
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWY
    PMA / PMN Number
    PK123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4), JUN 30, 2019. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A PERIPROSTHETIC FRACTURE. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671662 CORAIL2 LAT COXA VARA SIZE 15 HIP FEMORAL STEM/SLEEVE KWY DEPUY FRANCE SAS 3003895575 5231328

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention