BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB XLK INS 3 12.5MM

    MDR report key: 2961507 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-12375
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 5, 2013
    Report Date
    January 5, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK040166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SIG MOD TIB TRAY CEM COCR DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION FOR THE SIGMA STAB XLK INS SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. 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 THE PRODUCT OR 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65423 SIGMA STAB XLK INS 3 12.5MM TIBIAL KNEE INSERT JWH 9616671 DEPUY (IRELAND) 2362228

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention