BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 8

    MDR report key: 2162256 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-11734
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 10, 2011
    Manufacturer
    DEPUY INTL., LTD
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS NOT RECEIVED FOR INVESTIGATION. THE DATE OF PRIMARY IMPLANT WAS NOT PROVIDED SO THE TIME IN VIVO IS UNKNOWN. THE DATES OF THE X-RAYS ARE UNKNOWN. THE DISTAL STEM IS IN A VALGUS POSITION AND IN CONTACT WITH THE FEMORAL CORTEX WITH SOME INDICATION OF BONE REMODELING AROUND THE DISTAL STEM TIP. THIS MAY HAVE CONTRIBUTED TO THE REPORTED THIGH PAIN. THE STEM FIXATION IS UNKNOWN AS THE X-RAY IS NOT OF SUFFICIENT QUALITY TO IDENTIFY. THE LEG LENGTH MAY BE SIMILAR TO THE CONTRALATERAL HOWEVER WITH THE INFORMATION PROVIDED THIS CANNOT BE CONCLUDED. THE CUP IS INCLINED AT APPROXIMATELY 42 WITH VERSION. WITH THE X-RAYS PROVIDED IT IS NOT POSSIBLE TO GIVE ANY ADDITIONAL COMMENTS ON CUP POSITION THE CUP HAS AT LEAST 2 SCREWS FOR ADDITIONAL FIXATION. UNDETERMINABLE, WITH THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE IMPLANT FAILURE. IT IS POSSIBLE THAT THE POSITION OF THE STEM WAS A CONTRIBUTING FACTOR TO THE THIGH PAIN EXPLAINED IN THE COMPLAINT DESCRIPTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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

    THIGH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 8 87 KWA, LZO, MEH, LWJ KWA DEPUY INTL., LTD NA 5004770

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention