BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC3 RP TIBIAL INSERT S3,17.5

    MDR report key: 2992680 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13364
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 FOR THE MBT REVISION CEM TIB TRAY, MBT TRAY SLEEVE POR, MBT STEP WEDGE OR THE TC3 RP TIBIAL INSERT SINCE THEIR RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE TIBIAL STEM, POSTERIOR AUGMENT, DISTAL AUGMENTS OR FEMORAL STEM AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE PFC*SIGMA TC3 FEM OR THE PFC*SIGMA/OV/DOME PAT AS THE LOT CODES REQUIRED WERE NOT PROVIDED. THE INITIAL REPORTING STATED THAT NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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 INFECTION. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97059 TC3 RP TIBIAL INSERT S3,17.5 TIBIAL KNEE INSERT NJL 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC AL6GV4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention