BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 23216368 · Received October 3, 2025

    Report

    Report Number
    1644408-2025-01417
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 5, 2025
    Report Date
    December 6, 2025
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    JWH
    PMA / PMN Number
    K230169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE D4 EXPIRATION DATE, H4, H6, AND H11. THE AGENT REPORTED "(PATIENT FELL POST OPERATIVELY AND OPENED SURGICAL SITE)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 29 DAYS APART. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEMS ASSOCIATED WITH THIS INVESTIGATION WERE 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 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 DEVICES WERE DEFECTIVE. THE SURGEON PERFORMED THIS PROCEDURE TO REMEDY THE PATIENT'S CONDITION. NO FURTHER ACTION IS DEEMED NECESSARY. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOW THAT THE REPORTED COMPONENTS USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. FIRST, THERE WAS AN NCMR#70817 ASSOCIATED WITH THE MAIN PART #348-22-709, EMPOWR REVISION KNEETM REV VVC+ TIBIAL INSERT E+, SZ 9, 22MM WHICH DOCUMENT THAT OUT OF 10 PARTS LOT ALL ITEMS WERE REJECTED AND SCRAPPED DUE TO LABEL REPRINTED ON THE LR FORM WAS NOT BACKDATE PROPERLY. LATER, THE REJECTED WERE REWORKED AND ACCEPTED AFTER PROPER JUSTIFICATION. SECOND, THERE WAS AN NCMR#64908 ASSOCIATED WITH THE CONCOMITANT PART #346-22-101, EMPOWR REINFORCEMENT PIN, LARGE, 22MM WHICH DOCUMENT THAT OUT OF 60 PARTS LOT ALL ITEMS WERE REJECTED DUE TO SIZE VERIFICATION DIMENSION IS INCORRECT ON CATALOG LEVEL PRINT. LATER, THE REJECTED WERE REWORKED AND ACCEPTED AFTER PROPER JUSTIFICATION. ALL OTHER ITEMS IN THE LOT WERE MET WITH FIT, FORM AND FUNCTION REQUIREMENTS. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICES 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 FALL. 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. AGENT HAS CLEARLY MENTIONED THAT "PATIENT FELL", DUE TO SHORT TIME BETWEEN PREVIOUS AND REVISION SURGERY, IT IS POSSIBLE THAT THE EVENT MAY HAVE OCCURRED DUE TO LACK OF POST-OPERATIVE CARE, PATIENT NONCOMPLIANCE WITH MEDICAL INSTRUCTIONS OR INCORRECT IMPLANT SELECTION, PROLONGED OVERHEAD ACTIVITIES, PATIENT ACTIVITIES OR TRAUMA. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE 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.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO PATIENT FELL POST OPERATIVELY AND OPENED SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95023 DJO SURGICAL EMPOWR REVISION KNEETM REV VVC+ TIBIAL INSERT E+, SZ 9, 22MM JWH ENCORE MEDICAL L.P. 4660A1002

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other 346-22-101, LOT: 171Y1004.