BEUDAMED
    FDA Adverse Event Death Summary report: N

    DJO SURGICAL

    MDR report key: 19965576 · Received August 12, 2024

    Report

    Report Number
    1644408-2024-01331
    Event Type
    Death
    Date Received
    August 12, 2024
    Date of Event
    October 9, 2023
    Report Date
    November 19, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    FZX
    UDI-DI
    00888912166638
    PMA / PMN Number
    K143242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE D3, D4 EXPIRATION DATE, G1, H4, H11. THE AGENT REPORTED "(EXSANGUINATION DUE TO LACERATION OF THE LEFT POPLITEAL ARTERY, DUE TO MECHANICAL FAILURE OF LEFT PROSTHETIC KNEE JOINT)." THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 2.5 YEARS APART. NOTE: THERE WAS NO PREVIOUS DTICKET PROVIDED OR FOUND AFTER A SEARCH, THEREFORE, THE TIME IN VIVO COULD BE DETERMINED AND THE LISTED ITEMS COULD NOT BE VERIFIED. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEM(S) ASSOCIATED WITH THIS INVESTIGATION WAS NOT RETURNED TO DJO SURGICAL - AUSTIN FOR EXAMINATION. 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 OTHER 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 THAT THE REPORTED DEVICE(S) 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(S) SHOW THAT THE REPORTED COMPONENT(S) USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT(S) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE(S) 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(S) 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 A LACERATION OF THE LEFT POPLITEAL ARTERY. NO OTHER 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 CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL.

    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.

    Additional Manufacturer Narrative · 0

    SEE H11 THE DEMAND LETTER REPORTS THEIR CLIENT PASSED AWAY FROM "(EXSANGUINATION DUE TO LACERATION OF THE LEFT POPLITEAL ARTERY, DUE TO MECHANICAL FAILURE OF LEFT PROSTHETIC KNEE JOINT)." THE TIME IN-USE FOR THE ITEM(S) LISTED IS 6.7 YEARS. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEM(S) ASSOCIATED WITH THIS INVESTIGATION WAS NOT RETURNED TO DJO SURGICAL - AUSTIN FOR EXAMINATION. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. THERE WAS NO OTHER 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 THAT THE REPORTED DEVICE(S) WAS DEFECTIVE. NO FURTHER ACTION IS DEEMED NECESSARY. A REVIEW OF THE DEVICE HISTORY RECORD(S) SHOW THAT THE REPORTED COMPONENT(S) USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT(S) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE(S) 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(S) 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 IS DUE TO A LACERATION OF THE LEFT POPLITEAL ARTERY FROM A MECHANICAL FAILURE OF LEFT PROSTHETIC KNEE JOINT. NO OTHER 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 CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2023 FROM "EXSANGUINATION DUE TO LACERATION OF THE LEFT POPLITEAL ARTERY, DUE TO MECHANICAL FAILURE OF LEFT PROSTHETIC KNEE JOINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485053 DJO SURGICAL EMPOWR 3D KNEETM FEMUR, NP, 6L FZX ENCORE MEDICAL L.P. 939R1080 00888912166638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| D 130-03-729 LOT: 154N1148| 341-12-706 LOT: 110T1029| 351-03-106 LOT: 023T1031