BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 3072939 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15765
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    July 21, 2012
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REASON FOR REVISION WAS NOT PROVIDED AND THEREFORE NO CONCLUSIONS CAN BE DRAWN. FURTHER INFORMATION REGARDING THIS REPORT WAS NOT MADE AVAILABLE TO CUSTOMER QUALITY. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    INFORMATION RECEIVED FROM KENNEDY'S. CONFIRMED REVISION OF PINNACLE IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    CONFIRMED REVISION OF PINNACLE IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174363 CORAIL2 STD SIZE 11 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 5012340

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention