BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21209489 · Received January 22, 2025

    Report

    Report Number
    3010536692-2025-00006
    Event Type
    Injury
    Date Received
    January 22, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS7S14L1
    PMA / PMN Number
    K093552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. REVIEW OF THE COMPLAINT, ETPKN7SL LOT 1950429, EFSRN4PL LOT UNK, EIS7S14L LOT 1827506, AND KPONTP38 LOT 1912160, DOES NOT REVEAL ANY FAILURE INVOLVING THIS IMPLANT. MPO WAS MADE AWARE OF THIS INCIDENT THROUGH THE UNITED KINGDOM NATIONAL JOINT REGISTRY. THE REVISED PRODUCTS WERE NOT RETURNED, AND NO EXPLANT IMAGES, RADIOGRAPHS, OPERATIVE NOTES, OR OTHER CLINICALLY RELEVANT DOCUMENTATION IS AVAILABLE FOR REVIEW TO CONFIRM THIS OCCURRENCE OR SOURCE OF THE INFECTION. THIS IMPLANT WAS IMPLANTED IN A MALE PATIENT FOR APPROXIMATELY 18 MONTHS BEFORE REVISION DUE TO INFECTION WAS REQUIRED. THIS LOT WAS MANUFACTURED IN 2020 (EIS7S14L) AND 2022 (ETPKN7SL AND KPONTP38). IT IS UNKNOWN WHEN EFSRN4PL WAS MANUFACTURED DUE TO THE UNKNOWN LOT NUMBER. REVIEW OF THE DESIGN HISTORY RECORD (DHR) FOR THE SUBJECT MANUFACTURING LOTS INDICATES THAT THESE IMPLANTS WERE MANUFACTURED TO SPECIFICATION, INCLUDING ALL ASPECTS RELATED TO CLEANING AND STERILITY. THERE IS NO TREND FOR THESE IMPLANTS AND FAILURES. NO OPERATIVE NOTES OR OTHER CLINICALLY RELEVANT DOCUMENTATION HAVE BEEN PROVIDED TO CONFIRM THIS COMPLAINT. THE SOURCE OF THE INFECTION CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE MICROPORT KNEE SYSTEMS PACKAGE INSERT (150806) LISTS "DELAYED WOUND HEALING; DEEP WOUND INFECTION (EARLY OR LATE) WHICH MAY NECESSITATE REMOVAL OF THE PROSTHESIS" AS POSSIBLE ADVERSE EFFECTS OF TOTAL KNEE ARTHROPLASTY. WITHOUT ADDITIONAL DETAILS REGARDING THESE SPECIFIC CASES AND THE PRODUCTS INVOLVED, NO ADDITIONAL CONCLUSIONS CAN BE MADE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH COMPLAINT TRACKING. METHODS: DEVICE NOT RETURNED (4114). TREND ANALYSIS (4110). ANALYSIS OF PRODUCTION RECORDS (3331). RESULTS: NO FINDINGS AVAILABLE (3221). CONCLUSIONS: DEVICE MET SPECIFICATION. DEVICE WAS USED FOR TREATMENT. CAUSE NOT ESTABLISHED (4315). KNOWN INHERENT RISK OF DEVICE (22). CORRECT TYPE OF REPORTABLE EVENT: SERIOUS INJURY.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714077 EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 14MM LEFT KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS7S14L 1827506 M684EIS7S14L1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention