BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 3939633 · Received July 16, 2014

    Report

    Report Number
    1818910-2014-23610
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    January 22, 2014
    Report Date
    July 7, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    (B)(4). UPDATE REC'D 7/7/2014-PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION PROVIDED. A DOR WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THE PRIMARY OPERATIVE NOTE INDICATED A POLY LINER WAS IMPLANTED. THE CUP AND STEM ARE BEING ADDED TO THE COMPLAINT AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF THE PAIN. THE REVISION OPERATIVE NOTE INDICATED DISLOCATION AND AN OVERLY ANTEVERTED CUP. THE SURGEON DECIDED NOT TO REVISE THE CUP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2212971 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. WITH THE LIMITED AMOUNT OF INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DISLOCATION OF LINER AND HEAD. UPDATE REC'D (B)(4) 2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION PROVIDED. A DOR WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THE PRIMARY OPERATIVE NOTE INDICATED A POLY LINER WAS IMPLANTED. THE CUP AND STEM ARE BEING ADDED TO THE COMPLAINT AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF THE PAIN. THE REVISION OPERATIVE NOTE INDICATED DISLOCATION AND AN OVERLY ANTEVERTED CUP. THE SURGEON DECIDED NOT TO REVISE THE CUP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416564 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 1981528

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention