BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE13

    MDR report key: 2842739 · Received November 21, 2012

    Report

    Report Number
    1818910-2012-27991
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    August 26, 2012
    Report Date
    November 15, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR ANALYSIS: THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR FAILURE INVESTIGATION REPORT. THE HAC COATING WAS REALIZED IN CHAUMONT. PRODUCT ANALYSIS: VISUAL ANALYSIS OF THE RETURNED PRODUCT SHOWS A PARTIAL DISAPPEARANCE OF HYDROXYAPATITE WHICH IS NORMAL BECAUSE THE BODY NATURALLY ABSORBS AND INTEGRATES THE COATING IN THE MONTHS FOLLOWING IMPLANTATION. IT IS NOT NOTED OSTEOINTEGRATION ON THE STEM. RUPTURE OF THE NECK OF THE PROSTHESIS IS FOUND. THIS PROSTHESIS WAS ASSOCIATED WITH METAL BALL. THE PRODUCT WAS CHECKED DIMENSIONALLY AT VARIOUS SECTIONS (DRAWING (B)(4)). IT IS IN CONFORMITY WITH ITS DEFINITION. EXTERNAL LABORATORY(CRITT) ANALYSIS SHOWS THAT: THE FAILURE OF THE STEM IS DUE TO FATIGUE UNDER STRESS OF PLANE BENDING CYCLE TYPE. NO OVERLOAD WAS APPLIED ON THE IMPLANT. NO LASER MARK, MECHANIC HURT WHICH CAN HAVE WEAKENED THE STEM HAVE BEEN OBSERVED NEAR THE INITIATION RUPTURE AREA. MICROGRAPHIC EXAM DEPICTS A CORRECT MICROSTRUCTURE WITHOUT SIZEABLE METALLURGIC DEFECT NO NOTABLE DEFECT LIKE BULKY INCLUSION, COARSE MICROSTRUCTURE HAS BEEN OBSERVED NEAR THE SURFACE RUPTURE. THIS INDICATES THAT THE DAMAGE IS NOT DUE TO A BAD RAW MATERIAL OR A PROBLEM DURING FORGING/ MANUFACTURING BIOENGINEER ANALYSIS: THE X-RAY CONFIRMS THE FRACTURE. THE REASON FOR REVISION CANNOT BE IDENTIFIED FOR SURE. THE COMPLAINT DESCRIPTION STATES THAT THE HEAD WAS REVISED 4 YEARS PRIOR TO THE NECK FRACTURE, IN ORDER TO RESTORE THE LEG LENGTH. ALTHOUGH, NO DAMAGE ON THE STEM WAS IDENTIFIED BY THE EXTERNAL LAB AT THE FAILURE INITIATION, ONE CAN WONDER IF THAT PREVIOUS REVISION COULD HAVE PROMOTED THE FATIGUE FAILURE OF THE STEM. THE 3D SCANS SHOWN THAT THE NECK OF STEM IS 0.1MM BELOW THE MIDDLE DIMENSION AT THE FRACTURE LEVEL ON THE FRONTAL AND SAGITTAL PLANE. THIS VALUE IS CONFORMING TO DRAWING SPECIFICATION. ON THE CORNER SECTION, THE NECK IS 0.7MM BELOW THE MIDDLE DIMENSION, BUT THE PRINT DOESN'T REQUEST ANY INSPECTION AT THIS LEVEL OF 26MM. THE STRESS ON SCANNED MODEL IS 16% HIGHER THAN THE MIDDLE MODEL WHICH IS 4% HIGHER THAN THE MIN MODEL.

    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.

    Description of Event or Problem · 1

    DURING WALKING THE NECK OF THE STEM FRACTURED. NO TRAUMA WAS INVOLVED IN BREAKING THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE13 DEPUY STEM KWA DEPUY FRANCE 2460420

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention