BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 10

    MDR report key: 4541780 · Received February 24, 2015

    Report

    Report Number
    1818910-2015-14474
    Event Type
    Injury
    Date Received
    February 24, 2015
    Date of Event
    August 25, 2011
    Report Date
    January 29, 2015
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. THE COMPLAINT DATABASE SEARCH IDENTIFIED A PREVIOUS RELATED REPORT AGAINST LOT(S) 2112684 & 1915110. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE REMAINING PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S). MEDICAL RECORDS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. 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 INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, MULTIPLE DISLOCATIONS AND LACK OF MOBILITY. UPDATE 01/29/15: PFS RECEIVED. PFS IDENTIFIED PATIENT DOB, HEIGHT AND WEIGHT. UPDATE 01/29/2015: PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS PROVIDED. NO REVISION OPERATIVE NOTE WAS INCLUDED. LAB RESULTS FROM (B)(6) 2011 DID INDICATED HIGH METAL IONS LEVELS SO THE STEM IS BEING ADDED TO THE COMPLAINT. IT SHOULD BE NOTED THAT THE PATIENT WAS IMPLANTED WITH A POLY LINER DURING THE DOI. THE COMPLAINT WAS UPDATED ON: 02/23/2015. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129028 CORAIL2 NON COL HO SIZE 10 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 1915110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention