BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 14MM RIGH

    MDR report key: 21710994 · Received March 27, 2025

    Report

    Report Number
    3010536692-2025-00141
    Event Type
    Injury
    Date Received
    March 27, 2025
    Report Date
    December 4, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS7S14R1
    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

    THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. THIS 59-YEAR-OLD MALE PATIENT WAS REVISED APPROXIMATELY 7 MONTHS AFTER THE PRIMARY OPERATION DUE TO AN ALLEGED INFECTION. DURING THE REVISION OPERATION, THE SUBJECT 14MM TIBIAL INSERT, EIS7S14R, WAS REPLACED WITH A 17MM TIBIAL INSERT. THE REVISED IMPLANT WAS NOT RETURNED. ADDITIONALLY, MPO HAS NOT RECEIVED ANY CLINICAL INFORMATION TO CONFIRM THE PRESENCE OR SOURCE OF INFECTION. THIS LOT WAS MANUFACTURED IN 2022. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT LOT INDICATES THAT THIS PART MET ALL ESTABLISHED ACCEPTANCE CRITERIA THROUGHOUT MANUFACTURING PROCESSES, INCLUDING ALL ASPECTS RELATED TO CLEANING AND STERILIZATION PROCESSES. FURTHERMORE, REVIEW OF HISTORICAL COMPLAINT DATA CONFIRMS NO OTHER REPORTED INSTANCES FOR THE SUBJECT MANUFACTURING LOT, AND NO TRENDS WERE IDENTIFIED FOR THE OTHER MANUFACTURING LOTS FROM THE SAME STERILE BATCH. INFECTION IS A KNOWN POSSIBLE ADVERSE EFFECT OF ANY SURGICAL PROCEDURE AND IS CAPTURED WITHIN MPO RISK MANAGEMENT AND RELEVANT KNEE SYSTEMS PACKAGE INSERT. CONCLUSIONS REGARDING THE SOURCE OF INFECTION OR OTHER POSSIBLE CONTRIBUTING FACTORS CANNOT BE MADE FOR THIS CASE. TREND ANALYSIS REVEALS A LARGE SPIKE IN COMPLAINTS FOR INFECTION INVOLVING THIS PRODUCT FAMILY WAS CAPTURED DURING MARCH 2025. THE MAJORITY OF THESE REPORTS ARE FROM A GERMAN REGISTRY SOURCE WITHOUT AND PRODUCT OR LOT IDENTIFYING INFORMATION OR OTHER DETAILS REGARDING EACH INSTANCE. THERE WERE NOT ANY TRENDS IDENTIFIED FOR THE KNOWN MANUFACTURING LOTS FOR COMPLAINTS IN THE TREND PERIOD. DFMEA COMPARISON SHOWS NO CHANGES IN OCCURRENCE LEVEL. THEREFORE, BASED ON THESE INVESTIGATION FINDINGS, ADDITIONAL TREND ANALYSIS OR OTHER ESCALATION IS NOT DEEMED NECESSARY AT THIS TIME. MPO WILL CONTINUE TO BE MONITORED THROUGH COMPLAINT TRACKING.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2024. REVISED ON (B)(6) 2025 DUE TO INFECTION. 14MM INSERT REPLACED WITH 17MM. NON REVISED MPO PRODUCTS: PRODUCT ID: KPONTP38 LOT:1912161 ADVANCE ONLAY ALL-POLY PATELLA. PRODUCT ID: ETPKN7SR LOT: 1993345 EVOLUTION MP TIBIAL BASE. PRODUCT ID: EFSRN7PR LOT: 1994371 EVOLUTION MP CS/CR FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434191 EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 14MM RIGH KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS7S14R 1913611 M684EIS7S14R1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention