BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DEVICE

    MDR report key: 2931605 · Received January 28, 2013

    Report

    Report Number
    1818910-2013-02247
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    October 17, 2012
    Report Date
    December 29, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 REPORTED EVENT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WERE NOT PROVIDED. RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE NEWLY PROVIDED INFORMATION. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE TIBIAL TRAY AT THE BONE/CEMENT INTERFACE, CEMENT MFR IS UNKNOWN. OSTEOLYSIS WAS NOTED. (B)(4) 2012 - CLINICAL REPORT RECEIVED. CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AND A PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36644 UNKNOWN DEPUY DEVICE UNKNOWN JWH DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention