BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC KEEL TIB TRAY CEM SZ4

    MDR report key: 3223890 · Received July 12, 2013

    Report

    Report Number
    1818910-2013-21055
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PATIENT X-RAYS WERE PROVIDED WITH THE INITIAL REPORTING. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INPUTS WERE PROVIDED. BASED ON THE POOR QUALITY OF THE PROVIDED X-RAY IMAGES, THE PRESENCE OF LOOSENING CANNOT BE CONFIRMED. THE INVESTIGATION COULD NOT CONFIRM THE REPORTED EVENT OR IDENTIFY ANY PRODUCT CONTRIBUTION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO CONFIRM THE REPORTED EVENT OR DETERMINE A ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY. THE LOOSENING INTERFACE IS UNKNOWN. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323478 PFC KEEL TIB TRAY CEM SZ4 TIBIAL KNEE PROSTHESIS JWH 3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH D12011658

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention