BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 22487407 · Received July 11, 2025

    Report

    Report Number
    1644408-2025-01010
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LZO
    UDI-DI
    00190446843641
    PMA / PMN Number
    K241483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED "(HEAD/LINER SWAP)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 30 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. THERE WAS A NONCONFORMANCE ASSOCIATED WITH THE CONCOMITANT PART #941-01-40H, EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+,40H, WHICH DOCUMENTS THAT OUT OF 20 PARTS LOT, 1 ITEM WAS REJECTED AND SCRAPPED DURING PART VERIFICATION. ALL OTHER ITEMS IN THE LOT WERE MET WITH FIT, FORM AND FUNCTION. 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 UNKNOWN REASON. 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. 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, INCORRECT IMPLANT SELECTION, PATIENT ACTIVITIES OR TRAUMA. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL.

    Description of Event or Problem · 0

    REVISION SURGERY - HEAD/LINER SWAP, UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678966 DJO SURGICAL HEAD, FEMORAL, CERAMYS, 40MM, M, 0MM LZO ENCORE MEDICAL L.P. 6110643 00190446843641

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention 941-01-40H LOT: 605Z1291.