BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY TIBIAL TRAY

    MDR report key: 4213611 · Received October 30, 2014

    Report

    Report Number
    1818910-2014-30923
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    October 3, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER ARE NOT AVAILABLE.

    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 X-RAYS AND MEDICAL RECORDS WERE PROVIDED. THE X-RAY QUALITY WAS NOT ADEQUATE FOR REVIEW AND NO CONCLUSIONS COULD BE DRAWN. THE REVISION OPERATIVE NOTE WAS PROVIDED AND LISTED PAIN AS THE PREOPERATIVE DIAGNOSIS AND PATELLOFEMORAL TRACKING DISORDER AS THE SECONDARY DIAGNOSIS. THE SURGEON STATED THERE WAS SOME SYNOVITIS OCCURRING THAT WAS REMOVED. WITH THE LIMITED AMOUNT OF INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE REC¿D 10/03/2014- PATIENT'S MEDICAL RECORDS AND X-RAYS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THE MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED FOR PATELLA TRACKING ISSUES ALONG WITH PAIN. THE PATIENT'S TIBIAL TRAY IS BEING REPORTED ALONG WITH THEIR PATELLAR IMPLANT. THE COMPLAINT WAS UPDATED ON: 10-30-2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696083 UNKNOWN DEPUY TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention