BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL COMP

    MDR report key: 3812389 · Received May 15, 2014

    Report

    Report Number
    1818910-2014-18833
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS WERE PROVIDED. REVIEW OF THE SUPPLIED INVESTIGATIONAL INPUTS CONFIRMED THE REPORTED CONCERN. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT CODE AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT BASED ON THE AVAILABLE INFORMATION. BASED ON THE INABILITY TO IDENTIFY 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

    PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. UPDATE REC¿D (B)(4) 2014- PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THE PATIENT'S FEMORAL COMPONENT WAS FOUND TO BE LOOSE. ALSO NOTED, WAS EXTENSIVE OSTEOLYSIS ON THE DISTAL FEMUR AND WEAR OF THE TIBIAL INSERT. THE FEMORAL COMPONENT AND TIBIAL INSERT ARE BEING ADDED TO THE COMPLAINT. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291667 UNKNOWN DEPUY FEMORAL COMP KNEE FEMORAL COMPONENT JWH DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention