BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 9

    MDR report key: 4131307 · Received October 1, 2014

    Report

    Report Number
    1818910-2014-29172
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 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.

    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

    A REVIEW OF MANUFACTURING RECORDS AND COMPLAINTS DATABASE DID NOT IDENTIFY ANY ANOMALIES. THE PRODUCTS WERE TRANSFERRED TO APPLIED RESEARCH FOR ANALYSIS. A REPORT WAS RECEIVED STATING THERE WERE NO REPORTS OF POOR FIXATION OF THE STEM FROM THE COMPLAINANT. THE PRESENCE OF BONE ALONG THE LENGTH OF THE STEM SUGGESTS THAT THE STEM MAY HAVE BEEN WELL FIXED IN-VIVO. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THERE WERE REGIONS ALONG THE LENGTH OF THE STEM WHERE THE HYDROXYAPATITE COATING COULD STILL BE SEEN. THIS SUGGESTS A LACK OF UNIFORM OSSEOINTEGRATION ONTO THE HYDROXYAPATITE-COATED SURFACE OF THE STEM. THE PATIENT WAS REVISED DUE TO THIGH PAIN AND RECURRENT DISLOCATION. THERE WAS NO VISIBLE EVIDENCE TO SUGGEST MICRO-MOTION OR IMPINGEMENT ON THE FEMORAL COMPONENTS PROVIDED. THE PARTS AND LAB REPORT WERE TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED (B)(4) STATING BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION WAS UNDETERMINED. THE CUSTOMER REPORTED A DEVICE DEFECT. IT IS UNLIKELY THAT THERE WAS A MANUFACTURING FAULT. THE MODE OF FAILURE OF THE PROSTHESIS IS MULTI-FACTORIAL AND CONSIDERATION HAS TO BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS, SURGICAL PROCESS, PATIENT VARIABLES I.E. ACTIVITY, WEIGHT, BMI AND USE, ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. THIS REPORT DETAILS THE FINDINGS FROM A REVIEW OF THE EXPLANTS AND INFORMATION AS SUPPLIED AT THE TIME OF EVALUATION. ANY CONCLUSIONS FROM THIS DATA HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. NO CORRECTIVE ACTION IS REQUIRED. POST MARKET SURVEILLANCE IS PER SEP-419.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFG. (10/16/2014). MANUFACTURE DATE SEP 18, 2007. 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.

    Description of Event or Problem · 1

    PRIMARY SURGERY (B)(6) 2011, ASR XL REVISION. REVISION SURGERY (B)(6) 2014. THIS PROCEDURE WAS A REVISION OF A REVISION. THE FIRST REVISION WAS PERFORMED FOLLOWING AN ASR XL/CORAIL PROCEDURE WHERE THE ASR CUP WAS REMOVED AND REPLACED WITH A TRIDENT CUP. CORAIL STEM WAS LEFT IN SITU. TODAY THE CORAIL STEM WAS REMOVED DUE TO THIGH PAIN AND RECURRENT DISLOCATION.

    Description of Event or Problem · 1

    POTENTIAL PROBLEM WITH THE TAPER ON THE STEM WHICH WAS CAUSING METAL DEBRIS WITH THE CERAMIC HEAD. PRIMARY SURGERY (B)(6) 2011. ASR XL REVISION. PATIENT HAS A UNIQUE ASR NUMBER IF DETAILS ARE NEEDED. REVISION SURGERY (B)(6) 2014. THIS PROCEDURE WAS A REVISION OF A REVISION. THE FIRST REVISION WAS PERFORMED FOLLOWING AN ASR XL/CORAIL PROCEDURE WHERE THE ASR CUP WAS REMOVED AND REPLACED WITH A TRIDENT CUP. CORAIL STEM WAS LEFT IN SITU. TODAY THE CORAIL STEM WAS REMOVED DUE TO THIGH PAIN AND RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611880 CORAIL2 STD SIZE 9 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 2425501

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention