BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY HV CEMENT

    MDR report key: 3805591 · Received May 12, 2014

    Report

    Report Number
    1818910-2014-18549
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. 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

    THIS IS A DUPLICATE REPORT OF 1818910-2014-18536. THIS REPORT, 1818910-2014-18549, WILL BE REJECTED. 1818910-2014-18536 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO TIBIAL TRAY LOOSENING. LOOSENING WAS AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT AND TIBIAL TRAY HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284620 UNKNOWN DEPUY HV CEMENT CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention