BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ENDULANCE HEAD 28 MM

    MDR report key: 3914834 · Received July 4, 2014

    Report

    Report Number
    1818910-2014-22714
    Event Type
    Injury
    Date Received
    July 4, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN X-RAY WAS RECEIVED AND WAS TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED STATING THAT THE ROOT CAUSE IS UNDETERMINED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION WAS UNDETERMINED. THE CUSTOMER DID NOT REPORT A DEVICE DEFECT. IT IS UNLIKELY THAT THERE WAS A MANUFACTURING FAULT. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO LOT NUMBERS WERE RECEIVED. COMPLAINTS DATABASES SEARCHED ON PRODUCT CODE (B)(4) IDENTIFIED SIMILAR COMPLAINTS RECEIVED PREVIOUSLY. A COMPLAINTS DATABASE SEARCH COULD NOT BE CONDUCTED ON THE OTHER PRODUCTS AS NO PRODUCT NUMBERS WERE RECEIVED. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATION FURTHER. 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.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO THE PAIN CAUSED BY THE THA PERFORMED 7 YEARS AGO. DOI UNKNOWN. THE PATIENT HAD BEEN EXPERIENCING A PAIN IMMEDIATELY AFTER THE SURGERY. THE COMPLAINED IMPLANTS WERE SAFELY REMOVED WITHOUT USING INSTRUMENTS, AND REPLACED WITH EXETER BY IBG PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATION, AND THERE WAS NO DELAY. THE PHYSICIAN PRESUMES THAT THE PAIN WAS CAUSED BY THE UNDER-SIZED IMPLANTS, THUS THEY DID NOT SCRATCH FIT TO THE BONES AND WERE NOT FIRMLY FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392790 UNIDENTIFIED ENDULANCE HEAD 28 MM HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention