BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 2912931 · Received January 14, 2013

    Report

    Report Number
    1818910-2013-10862
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 8, 2013
    Manufacturer
    DEPUY FRANCE
    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE SHOWS A DISAPPEARANCE OF THE HYDROXYAPATITE, WHICH IS NORMAL BECAUSE NATURALLY THE HUMAN ORGANISM INTEGRATES AND ABSORBS THIS COATING IN THE MONTHS WHICH FOLLOW THE ESTABLISHMENT, IT IS PRACTICALLY NOT NOTED A PRESENCE OF OSSEOUSINTEGRATION. DIMENSIONAL EVALUATION OF THE DEVICE FINDS THE PRODUCT CONFORMS TO SPECIFICATIONS. A REVIEW OF DEVICE HISTORY RECORDS SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR FAILURE INVESTIGATION REPORT. 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 THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PATIENT HAD SURGERY 2 YEARS AGO AND CAME TO THE HOSPITAL WITH THE PAIN COMPLAINT. AFTER INVESTIGATIONS, THE PATIENT HAD REVISION SURGERY AND IT WAS SEEN THAT THE IMPLANT LOOSENED AND HA COATING WAS NOT EXISTING ALMOST ALL PART OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20099 CORAIL2 STD SIZE 11 FEMORAL STEM KWA DEPUY FRANCE 5001511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention