BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J/S PS BRG INSERTS LG 12.5MM

    MDR report key: 3013108 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-14139
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORTING STATED X-RAYS WERE NOT AVAILABLE FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT; HOWEVER, INFECTION AFTER APPROXIMATELY THIRTEEN YEARS IN VIVO IS UNLIKELY TO BE PRODUCT RELATED. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION, WHICH CAUSED OSTEOLYSIS AND LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE CEMENT/BONE INTERFACE. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN. POLY WEAR WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115030 J/S PS BRG INSERTS LG 12.5MM TIBIAL KNEE INSERT NJL 1818910 DEPUY ORTHOPAEDICS, INC. TH2BG1018

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention