BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT REVISION CEM TIB TRAY SZ 3

    MDR report key: 3192279 · Received June 27, 2013

    Report

    Report Number
    1818910-2013-19986
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 18, 2013
    Report Date
    June 3, 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
    KY, 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. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT HAD AN INTRAOPERATIVE COMPLICATION OF AN ANTERIOR SPLIT IN THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294308 MBT REVISION CEM TIB TRAY SZ 3 TIBIAL TRAY NJL 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 329156

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention