BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 19879410 · Received July 31, 2024

    Report

    Report Number
    1644408-2024-01266
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    FZX
    PMA / PMN Number
    K143242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO 1644408-2018-01100; 342-14-705, S809 - TRAUMA, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY, THE AGENT REPORTED "(PATELLA FRACTURE. POLY EXCHANGE)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 4 MONTHS APART. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEM ASSOCIATED WITH THIS INVESTIGATION WAS NOT RETURNED TO DJO SURGICAL - AUSTIN FOR REVIEW. THE SURGERY WAS COMPLETED AS INTENDED AND WITHOUT INCIDENT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICE WAS DEFECTIVE. THE SURGEON PERFORMED THIS PROCEDURE TO REMEDY THE PATIENT'S CONDITION. NO FURTHER ACTION IS DEEMED NECESSARY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS NO NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO FRACTURE. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL SUCH AS POOR BONE DENSITY, PATIENT BONE DETERIORATION, INADEQUATE SOFT TISSUE SUPPORT, PATIENT ACTIVITIES OR TRAUMA.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187659 DJO SURGICAL EMPOWR 3D KNEETM INS, 6R 12MM, VE FZX ENCORE MEDICAL L.P. 120T1122

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other| R