BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 14

    MDR report key: 4101382 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28467
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575
    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. NO REVISION OR REASON FOR REVISION HAVE BEEN CONFIRMED OR COMMUNICATED. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE FEMORAL STEM PRODUCT/LOT CODE COMBINATION AND NO OTHER REPORTS AGAINST THE REMAINDER. REVIEW OF THE FEMORAL STEM DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    REPORT OF FORMAL CLAIM RECEIVED REGARDING RIGHT SIDE PINNACLE/CORAIL IMPLANTS FROM (B)(6). NO CONFIRMATION OF REVISION, OR REASON FOR REVISION, RECEIVED. DOI - (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582055 CORAIL2 STD SIZE 14 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575 2199865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention