BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA TC3 FEM RT SZ2

    MDR report key: 4438966 · Received January 21, 2015

    Report

    Report Number
    1818910-2015-11660
    Event Type
    Injury
    Date Received
    January 21, 2015
    Date of Event
    June 18, 2013
    Report Date
    January 30, 2015
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AND IS PRESUMED YET IMPLANTED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A DEPUY MEDICAL PROFESSIONAL. REVIEW OF THE RECORDS CONFIRMED AN ARTHROSCOPY AND PARTIAL SYNOVECTOMY TO ADDRESS PAINFUL CREPITUS. FROM A MEDICAL PERSPECTIVE, BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AND IS PRESUMED YET IMPLANTED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. PATIENT MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A DEPUY MEDICAL PROFESSIONAL. REVIEW OF THE RECORDS CONFIRMED AN ARTHROSCOPY AND PARTIAL SYNOVECTOMY TO ADDRESS PAINFUL CREPITUS. FROM A MEDICAL PERSPECTIVE, BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    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). FOLLOW-UP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES SYMPTOMATIC PATELLA CREPITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49693 PFC*SIGMA TC3 FEM RT SZ2 KNEE FEMORAL COMPONENT JWH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 230279

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R