BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION®MP TIB KEELED NONPOR SIZE 3 STANDARD RIG

    MDR report key: 23709283 · Received December 3, 2025

    Report

    Report Number
    3010536692-2025-00388
    Event Type
    Injury
    Date Received
    December 3, 2025
    Report Date
    January 30, 2026
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    PMA / PMN Number
    K093552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THIS FEMALE PATIENT WAS REVISED AFTER APPROXIMATELY 4 MONTHS AFTER THE INDEX OPERATION DUE TO ALLEGED MALALIGNMENT. THE REVISED IMPLANTS WERE NOT RETURNED FOR INVESTIGATION, AND MPO HAS NOT RECEIVED IMAGES, RADIOGRAPHS, OR OPERATIVE NOTES FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT LOTS INDICATES THAT THESE IMPLANTS MET THE ESTABLISHED ACCEPTANCE CRITERIA THROUGHOUT MANUFACTURING PROCESSES. FURTHERMORE, THIS REPORT IS THE ONLY COMPLAINT INVOLVING THE SUBJECT MANUFACTURING LOTS. WITHOUT RADIOGRAPHS, MPO IS UNABLE TO COMPARE IMPLANT POSITIONING FROM THE TIME OF IMPLANTATION TO THE TIME OF REVISION FOR POTENTIAL CHANGES. ADDITIONALLY, MPO IS UNABLE TO EVALUATE POSSIBLE CONTRIBUTING FACTORS WITHOUT ADDITIONAL DETAILS REGARDING THIS CASE. THE CURRENT MPO KNEE SYSTEMS PACKAGE INSERT, STATES, "CARE SHOULD BE TAKEN TO RESTORE THE PROPER JOINT ALIGNMENT AND TO BALANCE LIGAMENTOUS TENSION. MALALIGNMENT OF THE JOINT CAN CAUSE EXCESSIVE WEAR, LOOSENING OF THE PROSTHESIS, AND PAIN LEADING TO PREMATURE REVISION OF ONE OR MORE OF THE PROSTHETIC COMPONENTS." THIS PACKAGE INSERT ALSO STATES, "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. EXCESSIVE ACTIVITY AND TRAUMA AFFECTING THE JOINT REPLACEMENT HAVE BEEN IMPLICATED WITH FAILURE OF THE RECONSTRUCTION BY LOOSENING, FRACTURE AND/OR WEAR OF THE PROSTHETIC COMPONENTS. 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." MPO DID NOT IDENTIFY ANY TRENDS INVOLVING THE SUBJECT DEVICES. MPO WILL CONTINUE TO MONITOR THIS COMPLAINT THROUGH COMPLAINT TRACKING.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2025. REVISED ON (B)(6) 2025. TIBIAL BASE AND INSERT REVISED DUE TO MALALIGNMENT. C25-314. MPO RELATED PRODUCTS: PRODUCT ID: KPONTP26, PRODUCT: ADVANCE® ONLAY ALL-POLY, LOT NO.: 1839076 QTY; 1. PRODUCT ID: EFSRN3PR, PRODUCT: EVOLUTION®MP FEM CS/CR NON-POR, LOT NO.: 1882332 QTY; 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855285 EVOLUTION®MP TIB KEELED NONPOR SIZE 3 STANDARD RIG KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. ETPKN3SR 1971245

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention