BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 3092597 · Received May 3, 2013

    Report

    Report Number
    1818910-2013-05442
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 19, 2011
    Report Date
    February 16, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE FEMORAL STEM PRODUCT/LOT CODE COMBINATION FINDS NO OTHER REPORTS SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS REGARDING THE REPORTED CORROSION. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. BLOODY AND METALLIC FLUID WAS COLLECTED FROM THE JOINT. SOFT TISSUE WAS STAINED THROUGHOUT THE JOINT. UPDATE A REVIEW OF MEDICAL RECORDS, CORROSION WAS NOTED INTEROPERATIVE ON THE TAPER. ALSO NOTED IN REVISION NOTES DURING THE IMPACTION OF THE CUP THERE WAS A SPLIT INTO THE SCIATIC NOTCH, HOWEVER A COMPETITORS DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194682 CORAIL2 STD SIZE 12 FEMORAL STEM HIP IMPLANT KWA DEPUY INTERNATIONAL 2753581

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention