BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 3802908 · Received May 9, 2014

    Report

    Report Number
    1818910-2014-18455
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    May 19, 2011
    Report Date
    April 14, 2014
    Manufacturer
    DEPUY FRANCE SAS REG. # 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

    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 SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED ONE OTHER REPORT AGAINST THE 2235661 FEMORAL STEM LOT CODE. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. AS THE CASE IS IN LITIGATION, FOLLOW UP FOR THIS ADDITIONAL INFORMATION WILL BE PERFORMED BY DEPUY LEGAL. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. 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.

    Description of Event or Problem · 1

    REPORT OF FORMAL CLAIM RECEIVED. CONFIRMED REVISION OF PINNACLE MOM. REASON FOR REVISION NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280527 CORAIL2 STD SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS REG. # 3003895575 2235661

    Patients

    Seq Age Sex Outcome Treatment
    1 Other