BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 10

    MDR report key: 2931116 · Received January 28, 2013

    Report

    Report Number
    1818910-2013-11550
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS STEM LOOSENING AND PAIN. IT WAS NOTED THAT THE STEM WAS WEDGED IN DISTALLY BUT SEEMED TO BE LOOSE PROXIMALLY. DOI (B)(6) 2010 - DOR (B)(6) 2013 (LEFT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. 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 AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS STEM LOOSENING AND PAIN. IT WAS NOTED THAT THE STEM WAS WEDGED IN DISTALLY BUT SEEMED TO BE LOOSE PROXIMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36612 CORAIL2 NON COL HO SIZE 10 FEMORAL HIP STEM KWA DEPUY FRANCE S.A.S.-SAINT PRIEST 5002060

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention