BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,38

    MDR report key: 3935014 · Received July 15, 2014

    Report

    Report Number
    1818910-2014-23409
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    August 1, 2012
    Report Date
    June 17, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS WERE PROVIDED AND REVIEWED. REVIEW OF THE RECORDS CONFIRMED LOOESNING OF THE TIBIAL COMPONENT AND OSTEOLYSIS. WITHIN THE INDICATIONS PORTION THE SURGEON NOTES THE PATIENT IS MORBIDLY OBESE, WAS REVISED 9 YEARS PRIOR AND HAD THE SAME FAILURE ON THE LEFT. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. IFU'S CAUTION SURGEONS IN THAT OBESITY TENDS TO IMPOSE SEVERE LOADING ON THE AFFECTED EXTREMITY PLACING THE PATIENT AT HIGHER RISK OF FAILURE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS 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.

    Description of Event or Problem · 1

    CLINICAL STATES MIGRATION, TIBIAL LOOSENING. THE INTERFACE AND CEMENT MANUFACTURER ARE UNKNOWN AT THIS TIME. UPDATE REC'D (B)(4) 2014 - THE COMPLAINT HAS BEEN REOPENED BECAUSE IT WAS REPORTED BY A SALES REP THAT THE PATIENT'S RIGHT KNEE WAS REVISED ON 05/27/2014 DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. THE CEMENT IS BEING ADDED TO THE COMPLAINT, AND THE COMPLAINT IS BEING CHANGED FROM MDR-NO TO MDR-YES. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014. UPDATE REC¿D (B)(4) 2014- PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS AREAS OF OSTEOLYSIS AS WELL. UPON REVISION THE PATIENT'S TIBIAL COMPONENT WAS FOUND TO BE DEBONDED FROM THE CEMENT. THE INSERT AND PATELLAR COMPONENTS ARE BEING REPORTED AT THIS TIME FOR THE OSTEOLYSIS. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412742 PFC*SIGMA/OV/DOME PAT 3PEG,38 KNEE PATELLAR COMPONENT JWH DEPUY IRELAND 9616671 1886694

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention