BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ENDURANCE CEMENT

    MDR report key: 3142178 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18034
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 6, 2013
    Manufacturer
    9610921 DEPUY CMW
    Product Code
    LOD
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    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. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). PATIENT OPERATIVE REPORTS AND X-RAYS WERE RECEIVED. REVIEW OF THE SUPPLIED INPUTS CONFIRMED OSTEOLYSIS AND DEBONDING BETWEEN THE CEMENT AND DEVICE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE OSTEOLYSIS OR DEVICE DEBONDING WITH INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A 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

    THE PATIENT WAS REVISED BECAUSE OF PAIN, OSTEOLYSIS, AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. UPDATE 05/06/2013 - PATIENT'S OPERATIVE REPORTS WERE RECEIVED. REPORTS INDICATE THE PATIENT'S TIBIAL AND FEMORAL COMPONENTS WERE DEBONDED FROM THE CEMENT MANTLE. DEPUY CEMENT WAS ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244488 UNKNOWN DEPUY ENDURANCE CEMENT CEMENT LOD 9610921 DEPUY CMW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR