BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM K9S HAC

    MDR report key: 2674010 · Received July 30, 2012

    Report

    Report Number
    1818910-2012-17664
    Event Type
    Injury
    Date Received
    July 30, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 10, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    LZO
    PMA / PMN Number
    K953111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE FOUND THE DEVICE MET SPECIFICATIONS BOTH IN THE HA COATING AND DIMENSIONALLY, AS FOUND ON DEPUY (B)(4). ANALYSIS OF THE RETURNED PRODUCTS SHOW 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 NOTED A PRESENCE OF OSSEOUSINTEGRATION. REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS THE STEM SIZING WAS NOT OPTIMAL AND THE STEM HAS SUBSIDED. A REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    REVISION SURGERY PERFORMED DUE TO PAIN. REASON WAS RELEASED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL STEM K9S HAC DEPUY HIP IMPLANT LZO DEPUY FRANCE TE1403598

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention