BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 25179180 · Received May 14, 2026

    Report

    Report Number
    1644408-2026-00897
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LPH
    UDI-DI
    00190446311577
    PMA / PMN Number
    K190057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED, "IMPLANT PACKING HAS YELLOWISH TENT AND DOCTOR WAS CONCERNED WITH USING IMPLANT. NEED A EXPLANT KIT MAIL TO OFFICE TO SHIP CUP BACK. 8054 SUMMA AVE STE C BATON ROUGE LA 70809." ITEM NUMBER: 940-02-54G "ITEM DESCRIPTION: EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 54MM" LOT#: 801Z1550 PART REVISION: C PRODUCT TYPE: HIP MANUFACTURE DATE: 18-FEB-2026 EXPIRATION DATE: 13-FEB-2032 THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. THE SURGEON REPORTED NO RISK OR ADVERSE EVENT, AND THE SURGERY WAS COMPLETED AS INTENDED WITH NO DELAY. THE DEVICE WAS INSPECTED PRIOR TO USE AND DEEMED UNACCEPTABLE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY AND WAS ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. RMA EXAMINATION: THE REPORTED DEVICE WAS NOT RETURNED TO ENOVIS SURGICAL FOR EVALUATION. NO FURTHER EVALUATION CAN BE MADE FOR THIS EVENT. THIS CUSTOMER COMPLAINT WILL BE CLOSED. IF THE DEVICE IS RETURNED LATER, THE COMPLAINT WILL BE UPDATED. ROOT CAUSE: THE REPORTED ISSUE OF YELLOW PACKAGING DISCOLORATION IS THE SAME FAILURE MODE PREVIOUSLY INVESTIGATED AND DETERMINED UNDER CAR-00835 (CC-00451617). THE ROOT CAUSE AND CORRECTIVE ACTIONS HAVE ALREADY BEEN ESTABLISHED. THIS COMPLAINT WAS EVALUATED TO CONFIRM THAT THE SAME FAILURE MECHANISM APPLIES TO THIS ITEM. NO ADDITIONAL FAILURE MODES, RISKS, OR NEW INFORMATION WERE IDENTIFIED. BASED ON THIS ASSESSMENT, THE PRIOR INVESTIGATION AND DETERMINATION APPLY TO THIS COMPLAINT. CONTAINMENT: CONTAINMENT ACTIVITIES WILL TAKE PLACE IN ACCORDANCE TO HHE-00063. DEVICE HISTORY RECORDS REVIEW: A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORDS (DHR) REVEALED, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NCMRS ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENT THAT IS RELATED TO THE REPORTED ISSUE. COMPLAINT HISTORY: THE CUSTOMER COMPLAINT HISTORY FOR THE REPORTED DEVICE(S) SHOWED NO CURRENT TRENDS OR ONGOING ISSUES THAT REQUIRE REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THER IMPLANT PACKING HAS YELLOWISH TINT AND DOCTOR WAS CONCERNED WITH USING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353475 DJO SURGICAL EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 54MM LPH ENCORE MEDICAL L.P. 801Z1550 00190446311577

    Patients

    Seq Age Sex Outcome Treatment
    1