BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PATELLAR COMPONENT

    MDR report key: 3961892 · Received July 28, 2014

    Report

    Report Number
    1818910-2014-24285
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Additional Manufacturer Narrative · 1

    REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE REPORTED OSTEOLYSIS COULD NOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. 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 A TIBIAL TRAY WHICH HAD BROKEN INTO TWO PIECES AND LOOSENED AT BOTH INTERFACES. THE FEMORAL COMPONENT WAS ALSO LOOSE AT BOTH INTERFACES. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437612 UNKNOWN DEPUY PATELLAR COMPONENT KNEE PATELLAR COMPONENT JWH DEPUY ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention