BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 10

    MDR report key: 3866544 · Received June 11, 2014

    Report

    Report Number
    1818910-2014-20706
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PSEUDOTUMOUR, RAISED METAL ION. REVISION TO HYBRID EXETER TRITANIUM. WIDE EXCISION OF PSEUDOTUMOUR. PRIMARY HIP DONE AT LGH BY ANOTHER SURGEON. CUP INCLINATION ALWAYS HIGH EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. PATIENT X-RAYS AND MEDICAL RECORDS WERE RECEIVED AND REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. 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 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.

    Additional Manufacturer Narrative · 1

    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

    PSEUDOTUMOUR, RAISED METAL ION. REVISION TO HYBRID EXETER TRITANIUM. WIDE EXCISION OF PSEUDOTUMOUR. PRIMARY HIP DONE AT (B)(6) BY ANOTHER SURGEON. CUP INCLINATION ALWAYS HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344160 CORAIL2 STD SIZE 10 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS REG. # 3003895575 2375489

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention