BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 10

    MDR report key: 3040028 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-14999
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    August 20, 2012
    Report Date
    June 11, 2013
    Manufacturer
    3003895575 DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A REVIEW OF DEVICE HISTORY RECORDS FOUNDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMED THE REPORTED STEM BREAKAGE FROM THE (B)(4) REVISION SURGERY. THE DISTAL STEM IN BOTH THE PRIMARY AND REVISION COMPLAINTS WERE NOTED TO BE FAVORED TOWARDS THE LATERAL WALL. THE INVESTIGATION CAN DRAW NO CONCLUSIONS 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013. DATE OF ORIGINAL SURGERY UPDATED: (B)(6) 2010.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO A BROKEN STEM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143470 CORAIL2 STD SIZE 10 HIP STEM KWA 3003895575 DEPUY FRANCE 3327567

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention