BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA CRVD XLK INS 5 8MM

    MDR report key: 2914153 · Received January 14, 2013

    Report

    Report Number
    1818910-2013-10865
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    DEPUY IRELAND ? REG. # 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK040166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. PATIENT MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS INCLUDING PROGRESS NOTES AND LAB RESULTS WERE PROVIDED AND REVIEWED BY A DEPUY ANALYST II. .D. NO PRODUCT PROBLEM HAS BEEN IDENTIFIED. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    BOTH KNEES APPEAR TO BE GROSSLY LOOSE ON XRAYS, BUT HAS NOT YET BEEN REVISED.**UPDATE** (B)(4) 2012 - IT HAS BEEN REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED ON (B)(4) 2012 DUE TO LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE CEMENT/BONE INTERFACE; HOWEVER, COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION, SO THE LOOSENING IS NOT ATTRIBUTED TO DEPUY PRODUCT. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21389 SIGMA CRVD XLK INS 5 8MM TIBIAL KNEE INSERT JWH DEPUY IRELAND ? REG. # 9616671 3202675

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other