BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 9

    MDR report key: 4192992 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30447
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 25, 2012
    Report Date
    October 10, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. NO REASON FOR REVISION HAS BEEN IDENTIFIED AND NO FURTHER INFORMATION OR INVESTIGATIONAL INPUTS HAVE BEEN MADE AVAILABLE. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE 1837698 LOT CODE. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINING PART/LOT COMBINATION. THE INVESTIGATION CAN DRAW NO CONCLUSION 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6). REASON FOR REVISION NOT PROVIDED. ADDITIONAL INFORMATION REPORTS PATIENT ACTIVITY LEVEL IMPAIRED, NO RESTRICTED ROM, CAN WALK 5-15 MINUTES WITHOUT PAIN. UPDATE 10 OCTOBER 2014 - COMPLAINT REOPENED AS FORMAL CLAIM RECEIVED FROM KENNEDYS. PATIENT COMPLAINING OF ACHING, DISCOMFORT AND PAIN. CLAIM CONFIRMS POSSIBLE RADIOLUCENCY NOTED IN (B)(6) 2012, ASSOCIATED WITH RIGHT ACETABULAR COMPONENT. CT SCAN (B)(6) 2012 SHOWED 2 CAVITIES IN RIGHT SIDE ACETABULAR. DURING REVISION TRUNNION WEAR NOTED WITH OXIDATION AND BLACKENING, BONE GRAFTING REQUIRED FOR CAVITIES. HISTOLOGY REPORT CONFIRMED ALVAL.

    Description of Event or Problem · 1

    UPDATE OCTOBER 18, 2017 - ADDITIONAL INFORMATION RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671825 CORAIL2 STD SIZE 9 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 1800781

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention