BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 11

    MDR report key: 3172984 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19048
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 17, 2013
    Manufacturer
    3003895575 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. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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

    DHR ANALYSIS: THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR BATCH (B)(4), THERE WAS NO DEVIATION. IT WAS RECORDED A FAILURE INVESTIGATION REPORT(2010-142). PARTS WERE DEFECTIVE IN APPEARANCE AFTER POLISHING AT SUBCONTRACTOR. THE PARTS WERE COMPLIANT AFTER RETOUCHING. X-RAY ANALYSIS (BY CPD LEEDS): THE STEM APPEARS TO BE VERY SMALL COMPARED TO THE SIZE OF THE FEMUR. THERE IS A SUBSTANTIAL RADIOLUCENT LINE THAT EXTENDS FROM THE LATERAL SHOULDER, DOWN ALMOST ALL OF THE LATERAL ASPECT OF THE STEM. THE IS ALSO A RADIOLUCENT LINE ON THE MEDIAL SIDE. THE EXTENT OF THE RADIOLUCENT LINES ARE AROUND THE STEM SUGGESTS THAT IT COULD BE LOOSE. THE STEM IS IN A VARUS POSITION IN THE X-RAY, HOWEVER IT IS NOT POSSIBLE TO CONFIRM IF THIS WAS THE RESULT OF IMPLANTATION IN THIS POSITION OR SUBSIDENCE, WITHOUT SIGHT OF THE POST OPERATIVE X-RAY. THE COMBINATION OF A RELATIVELY YOUNG PATIENT, WITH HIGH BMI AND AN UNDERSIZED STEM MAY BE PRONE TO IMPLANT SUBSIDENCE DUE TO HIGHER JOINT LOADS AND ACTIVITY LEVELS. NO FURTHER ANALYSIS WAS POSSIBLE BECAUSE THE PRODUCT (STEM) WAS NOT RETURNED.

    Description of Event or Problem · 1

    REASON FOR REVISION: ASCEPTIC LOOSENING.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2013, PRODUCT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273696 CORAIL2 NON COL HO SIZE 11 FEMORAL HIP STEM KWA 3003895575 DEPUY FRANCE 5034922

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention