BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP E

    MDR report key: 23767334 · Received December 10, 2025

    Report

    Report Number
    3010536692-2025-00390
    Event Type
    Injury
    Date Received
    December 10, 2025
    Report Date
    February 12, 2026
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDI
    UDI-DI
    M684DLXPGE361
    PMA / PMN Number
    K070785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 0

    THE ALLEGED COMPLAINT IS CONFIRMED. VISUAL REVIEW OF PROVIDED IMAGES AND RADIOGRAPHIC IMAGES OF THE IMPLANT, (B)(6) LOT 1902296, REVEALS THAT THE LINER IS WORN AND DAMAGED AND BECAME DISASSOCIATED. THIS IMPLANT WAS ORIGINALLY IMPLANTED IN (B)(6) 2022 IN THE 60 YO MALE PATIENT OF MEDIUM ACTIVITY LEVEL. THIS IMPLANT WAS REVISED IN (B)(6) 2025 DUE TO IMPLANT WEAR AND DISSOCIATION. THESE FAILURES WERE CONFIRMED THROUGH FOUR RADIOGRAPHIC IMAGES PROVIDED. THESE IMAGES SHOW THE IMPLANT AT 1-MONTH POST-SURGERY, 1-YEAR POST-SURGERY, 4 WEEKS PRIOR TO REVISION, AND 1 WEEK PRIOR TO REVISION. EXPLANTED IMAGES OF THE LINER SHOW WEAR AND DEFORMATION AROUND THE EDGES OF THE RIM AND LIPPED PORTIONS. IT IS UNCLEAR IF THIS DAMAGE WAS CAUSED BY IMPLANT USE OR IF THE DAMAGE WAS CAUSED BY THE SURGEON ATTEMPTS TO REMOVE THE IMPLANT. ADDITIONALLY, SCRATCHES AND MARKS CAN BE SEEN AROUND AND WITHIN THE LINER. THIS IMPLANT WAS MANUFACTURED IN 2022. REVIEW OF THE DESIGN HISTORY RECORD (DHR) FOR THE SUBJECT MANUFACTURING LOT INDICATES THAT THIS IMPLANT WAS MANUFACTURED TO SPECIFICATION. THERE ARE NO TRENDS FOR THIS IMPLANT AND FAILURE WITH THIS BEING THE FIRST COMPLAINT FOR DISASSOCIATION INVOLVING THIS FAMILY OF IMPLANTS RECEIVED SINCE OCTOBER 2024. THE CURRENT MPO HIP SYSTEMS PACKAGE INSERT, (B)(6), INCLUDES THE FOLLOWING STATEMENT AS A POSTOPERATIVE PRECAUTION: "THE PATIENT MUST BE ADVISED OF THE LIMITATIONS OF THE RECONSTRUCTION AND THE NEED FOR PROTECTION OF THE PROSTHESIS FROM FULL WEIGHT BEARING UNTIL ADEQUATE FIXATION AND HEALING HAVE OCCURRED. THE PATIENT SHOULD BE CAUTIONED TO LIMIT ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES AND POSSIBLE LOOSENING, FRACTURE AND/OR WEAR, AND FOLLOW THE INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. LOOSENING OF THE COMPONENTS CAN RESULT IN INCREASED PRODUCTION OF WEAR PARTICLES, AS WELL AS DAMAGE TO THE BONE, MAKING SUCCESSFUL REVISION SURGERY MORE DIFFICULT." THIS PACKAGE INSERT ALSO STATES, "PERIODIC, LONG-TERM FOLLOW-UP IS RECOMMENDED TO MONITOR THE POSITION AND STATE OF THE PROSTHETIC COMPONENTS, AS WELL AS THE CONDITION OF THE ADJOINING BONE. PERIODIC POST-OPERATIVE X-RAYS ARE RECOMMENDED FOR CLOSE COMPARISON WITH EARLY POST-OP CONDITIONS TO DETECT LONG TERM EVIDENCE OF CHANGES IN POSITION, LOOSENING, BENDING, OR CRACKING OF COMPONENTS." MPO WILL CONTINUE TO MONITOR THIS ISSUE THROUGH COMPLAINT TRACKING.

    Description of Event or Problem · 0

    ALLEGEDLY, LINER WORE THROUGH/BECAME DISASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871276 DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP E HIP COMPONENT JDI MICROPORT ORTHOPEDICS INC. DLXPGE36 1902296 M684DLXPGE361

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention