BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT REVISION CEM TIB TRAY SZ 2

    MDR report key: 3970657 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24669
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 1, 2010
    Report Date
    July 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REVIEW OF THE SUPPLIED MEDICAL RECORDS DID NOT FIND ANY EVIDENCE CONFIRMING THE REPORTED PATELLAR CREPITUS. THE RECORDS DID CONFIRM THE PATIENT HAD A LONG CEMENTED STEM PLACED PRIOR TO THIS REVISION AND WAS CONSIDERED A POSSIBLE SOURCE OF PAIN. DURING REVISION SURGERY SURGEON PERFORMED A SYNOVECTOMY AND REPLACED THE TIBIAL INSERT. 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.

    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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT WAS REVISED ON (B)(6) 2010 TO ADDRESS END-OF-STEM PAIN, AND THAT SHE EXPERIENCED PATELLAR CREPITUS BEGINNING (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446767 MBT REVISION CEM TIB TRAY SZ 2 KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS, INC.1818910 C26B11000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention