BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 25236854 · Received May 20, 2026

    Report

    Report Number
    1644408-2026-00965
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    JHW
    UDI-DI
    00190446735854
    PMA / PMN Number
    K143242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED, "PATIENT WAS TIGHT AND DIDN'T HAVE FULL FLEXION. 57 YR OLD FEMALE." THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 3 MONTHS, 15 DAYS APART. ITEM NUMBER: 341-11-704, "ITEM DESCRIPTION: EMPOWR 3D KNEETM INS, 4L 11MM, VE", LOT#: 3999A1006 , PART REVISION: C, PRODUCT TYPE: KNEE, MANUFACTURE DATE: 19-MAY-2022, EXPIRATION DATE: 16-MAY-2027. 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 NOT COMPLETED AS INTENDED. 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 THAT THE REPORTED DEVICE(S) WAS DEFECTIVE. THE SURGEON PERFORMED THIS PROCEDURE TO REMEDY THE PATIENT'S CONDITION. NO FURTHER ACTION IS DEEMED NECESSARY. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO LIMITED RANGE OF MOTION, AS THE PATIENT WAS TIGHT AND DID NOT ACHIEVE FULL FLEXION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING THE PATIENT'S PRE-EXISTING CONDITIONS OR ANY PATIENT ACTIVITIES THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE OF THE CONTROL OF ENOVIS SURGICAL. CONTAINMENT: 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. DEVICE HISTORY RECORDS REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWS THAT THE REPORTED COMPONENT(S) USED IN THE PREVIOUS SURGERY MET DESIGN AND MANUFACTURING REQUIREMENTS AT THE TIME OF RELEASE FOR USE. 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. COMPLAINT HISTORY: CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE(S) SHOWED NO PRESENT TRENDS OR ONGOING ISSUES THAT NEED REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO LOSS OF ROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452278 DJO SURGICAL EMPOWR 3D KNEETM INS, 4L 11MM, VE JHW ENCORE MEDICAL L.P 3999A1006 00190446735854

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention