BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 8

    MDR report key: 2840085 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-27438
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    **UPDATE** (B)(6) 2012 - CLINICAL REPORTS RECEIVED. CLINICAL REPORT STATES A REVISION FOR ASEPTIC LOOSENING OF THE STEM. THE MDR DECISION WAS CHANGED. DOR: (B)(6) 2012. **UPDATE** - (B)(6) 2012 - A REPORT RECEIVED FROM THE SALES REP REGARDING THE (B)(6) 2012 REVISION INDICATES THAT, IN ADDITION TO STEM LOOSENING, THERE WAS ALSO METALLOSIS. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. **UPDATE** (B)(6) 2013 - MEDICAL RECORDS RECEIVED. NO NEW INFORMATION RECEIVED THAT WOULD CHANGE THE EXISTING MDR DECISION. **UPDATE** (B)(6) 2013 - X-RAYS WERE RECEIVED. THE COMPLAINT WAS RE-OPENED. MEDICAL RECORDS AND X-RAYS WERE OBTAINED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT HAS MIGRATION AND LOOSENING OF THE STEM, BUT THERE HAS NOT YET BEEN A REVISION. (B)(6) 2012 - CLINICAL REPORTS RECEIVED. CLINICAL REPORT STATES A REVISION FOR ASEPTIC LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 8 FEMORAL STEM KWA DEPUY FRANCE 2144259

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention