BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM K9S HAC

    MDR report key: 2461301 · Received February 18, 2012

    Report

    Report Number
    1818910-2012-02003
    Event Type
    Injury
    Date Received
    February 18, 2012
    Report Date
    January 23, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 PRODUCT CONFIRMED THE REPORTED EVENT. THE VISUAL ANALYSIS SHOWS A DISTAL BREAK, HYPOTHESIS: THE RUPTURE IS RELATED TO A FATIGUE MECHANISM. THIS ANALYSIS SHOWS A RAW MATERIAL IN CONFORMITY, THE RUPTURE IS RELATED TO A FATIGUE MECHANISM. IT WAS CONCLUDE THAT THE STEM FAILED DUE TO A FATIGUE MECHANISM UNDER STRESS OF PLANE BENDING CYCLES TYPE AND NOT BECAUSE OF A BAD RAW MATERIAL. THE ORIGIN OF THE RUPTURE OF THE IMPLANT IS LIKELY THAT THE INTEGRATION OF THIS STEM WAS NOT OPTIMAL AND AS A RESULT OF SIGNIFICANT BENDING STRESSES APPEARED AT THE BASE OF THE STEM. THE PRESENCE OF (B)(4) PARTICLES HAS PROBABLY WEAKENED THE SURFACE OF THE IMPLANT, BUT IF THE INTEGRATION HAD BEEN CORRECT THE NOTCH EFFECT OF THE INCRUSTATIONS WOULD HAVE BEEN NEGLIGIBLE. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS SUBMITTED TO A TOTA HIP REPLACEMENT (B)(6) 2003. AFTER 8 YEARS, THE FEMORAL STEM HAS BROKEN. A REVISION SURGERY WAS PERFORMED TO EXTRACT THE BROKEN STEM AND A LONGER STEM WAS INTRODUCED (KAR STEM). PROCEDURE PROLONGED BY 120 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL STEM K9S HAC HIP STEM KWA DEPUY FRANCE 1476932

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention