BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 21862727 · Received April 17, 2025

    Report

    Report Number
    1644408-2025-00455
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 17, 2025
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LPH
    UDI-DI
    00190446311737
    PMA / PMN Number
    K190057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED "(CUP LOOSENING AND POSSIBLE INFECTION)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 2 YEARS AND 11 MONTHS APART. THIS EVALUATION IS LIMITED IN SCOPE AS LIMITED INFORMATION WAS PROVIDED TO DJO SURGICAL - AUSTIN FOR REVIEW. IF INFORMATION REGARDING CULTURES IDENTIFIED IN THE INFECTION, THE SEVERITY OF THE INFECTION OR ANY OTHER RELEVANT INFORMATION 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 DEVICES WERE THE SOURCE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. 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 A NONCONFORMANCE ASSOCIATED WITH THE CONCOMITANT PART #941-01-36G, EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 36G WHICH DOCUMENTS THAT OUT OF 20 PARTS LOT 4 ITEMS WERE REJECTED AND SCRAPPED DURING H202: GATHER OUTER PART MATERIAL. SECOND, THERE WAS AN NCMR#(B)(4) ASSOCIATED WITH THE CONCOMITANT PART #425-97-010, TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 10 WHICH DOCUMENT THAT OUT OF 12 PARTS LOT ALL ITEMS WERE REJECTED AND SCRAPPED DUE TO OXYGEN EXPOSURE. LATER, THE REJECTED PARTS WERE REWORKED AND ACCEPTED AFTER PROPER JUSTIFICATION THROUGH NDF. THIRD, THERE WAS AN NCMR#(B)(4) ASSOCIATED WITH THE CONCOMITANT PART #941-01-36G, EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+,36G WHICH DOCUMENT THAT OUT OF 40 PARTS LOT 3 ITEMS WERE REJECTED AND SCRAPPED DUE TO CANCELED IN STERILIZER DUE TO STARTING WRONG RECIPE. ADVANCED RECIPE WAS NOT STARTED BUT STANDARD WAS SELECTED AND STARTED. CANCELLED RUN TIME WAS 27 SECONDS IN CYCLE. LATER THE REJECTED PARTS WERE USED AS IS 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 INFECTION AND LOOSENING. 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 POSSIBLE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO LOOSENING AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32051 DJO SURGICAL EMPOWR ACETABULAR SYSTEM, CUP, HEMISPHERICAL, MULTI HOLE, 54 LPH ENCORE MEDICAL L.P. 816Z1017 00190446311737

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention 400-03-363 LOT: 868B1468| 425-97-010 LOT: 175R2284| 940-00-020 LOT: 145Z1056| 940-00-035 LOT: 148Z1041| 940-00-035 LOT: 148Z1106| 941-01-36G LOT: 599Z1003