BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SIZE 3 FB SIGMA TIBIAL TRAY

    MDR report key: 4131262 · Received October 1, 2014

    Report

    Report Number
    1818910-2014-29171
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNAVAILABLE. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER ARE NOT AVAILABLE. 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. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS AND X-RAYS RECEIVED. REVIEW OF THE SUPPLIED INVESTIGATIONAL INPUTS CONFIRMED LOOSENING OF THE TIBIAL COMPONENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING. AMONG OTHER CONDITIONS, EXCESSIVE PATIENT WEIGHT AND METABOLIC DISORDERS TEND TO ADVERSELY AFFECT JOINT REPLACEMENT IMPLANTS. IT IS NOT KNOWN TO WHAT EXTENT, IF ANY, THESE MAY HAVE BEEN A FACTOR IN THE REPORTED PROBLEM. ANY TOTAL JOINT ARTHROPLASTY HAS A RISK OF FAILURE DUE TO AN UNKNOWN COMBINATION OF FACTORS THAT INCLUDE PATIENT FACTORS, SURGICAL PROCESS AND SURGICAL TECHNIQUE. 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

    THE PATIENT HAD A FAILED TOTAL KNEE REPLACEMENT WITH A LOOSE TIBIAL TRAY THAT HAD FALLEN INTO A VARUS POSITION. THE PATIENT HAD A PAINFUL KNEE. THE LOOSENING OCCURRED AT THE CEMENT TO IMPLANT INTERFACE WITH AN UNKNOWN CEMENT MANUFACTURER. THE PATIENT'S MEDICAL RECORDS WERE ALSO REVIEWED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE MDR REPORTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611825 UNKNOWN DEPUY SIZE 3 FB SIGMA TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention