BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 2870689 · Received December 12, 2012

    Report

    Report Number
    1818910-2012-83576
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Product Problem
    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

    EXAMINATION OF THE RETURNED BROACHES FINDS NOTHING OUTWARD TO SUGGEST PRODUCT PROBLEM. THE FEMORAL STEM COMPONENT WAS NOT RETURNED FOR EXAMINATION. A REVIEW OF DEVICE HISTORY RECORDS FOR THE 3L92512/5127936 PRODUCT/LOT CODE COMBINATION FINDS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, NO DEVIATIONS OR FAILURE REPORTS WERE FOUND. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF PROVIDED PATIENT X-RAYS FINDS THAT DUE TO THE LACK OF QUALITY OF THE X-RAY PROVIDED, NO INFORMATION CAN BE OBTAINED. IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED. 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

    AFTER A PROGRESSIVE BROACHING OF THE FEMORAL CANAL, CALCAR REAMING AND TRIAL WITH BROACH NUMBER 12, THE SURGEON WAS UNABLE TO IMPLANT DEFINITIVE CORAIL STEM NUMBER 12, BECAUSE, IT WAS BLOCKED WITH HA LEVEL 1,5 CENTIMETER ABOVE OSTEOTOMY LINE. WITH FAILED ATTEMPTS AT EXTRACTION, THE SURGEON PERFORMED AN OSTEOTOMY TRANSFEMORAL. AFTER THE STEM REMOVED, APPLIED BROACH NUMBER 13 AND DISTALLY RHYMED WITH FLEXIBLE REAMER 12. FINALLY THE FEMORAL COMPONENT INSERTION HAD SUCCESS, BEING NECESSARY TO USE CERCLAGE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 12 DEPUY MANUAL INSTRUMENT KWA DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other