BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 10MM RIGH

    MDR report key: 21324536 · Received February 6, 2025

    Report

    Report Number
    3010536692-2025-00041
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 15, 2025
    Report Date
    December 24, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS7S10R1
    PMA / PMN Number
    K093552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    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 A PROVIDED IMAGE CONFIRMS THAT A LEFT TIBIAL INSERT IS MARKED AS A RIGHT TIBIAL INSERT, EIS7S10R LOT 2022829. THE REPORTING PERSON CONFIRMED THAT THE LEFT TIBIAL INSERT WAS A SIZE 7. DURING INVESTIGATION OF ORDERS THAT WERE PROCESSED AT THE SAME TIME, MPO IDENTIFIED A SUSPECT ORDER FOR A SIZE 7 LEFT TIBIAL INSERT, EIS7S10L LOT 2022838. THESE ORDERS WERE MACHINED A DAY APART BUT WERE AT THE LASER OPERATION ON THE SAME DAY. THOUGH DIFFERENT OPERATORS LASERED THE ORDERS, THE ORDERS WERE LIKELY AT THE WORK STATION TOGETHER BASED ON AVAILABLE EVIDENCE. AT FINAL INSPECTION, THREE PARTS FROM THE SUSPECT WORK ORDER, EIS7S10L LOT 2022838, WERE REJECTED. SPECIFICALLY, ONE OF THE ITEMS WAS SCRAPPED DUE TO HAVING OUT-OF-SPECIFICATION WEAR THICKNESS. BASED ON THIS INFORMATION, MPO BELIEVES THAT A ONE-TO-ONE SWAP OCCURRED BETWEEN EIS7S10R LOT 2022829 AND EIS7S10L LOT 2022838. THE SWAPPED PART IN THIS COMPLAINT IS THE LEFT PART, AND IT IS BELIEVED THAT THE CORRESPONDING RIGHT PART WAS SCRAPPED DUE TO HAVING OUT-OF SPECIFICATION WEAR THICKNESS MEASUREMENTS AT FINAL INSPECTION. THEREFORE, THE TWO SUBJECT ITEMS HAVE BEEN ACCOUNTED FOR, AND A DISTRIBUTED PRODUCT RISK ASSESSMENT IS NOT REQUIRED. MPO PREVIOUSLY INITIATED A CAPA REGARDING THE POTENTIAL FOR PRODUCT SWAPS. MORE SPECIFICALLY, ACTIONS DOCUMENTED THROUGH CAPA IS RELATED TO OPERATIONS ASSOCIATED WITH LINE CLEARANCE FOR LASER MARKING WORK STATIONS. THEREFORE, NO FURTHER ESCALATION IS DEEMED NECESSARY AS THIS ORDER WAS PROCESSED PRIOR TO IMPLEMENTATION OF THE CAPA ACTIONS. MPO WILL CONTINUE TO MONITOR FOR THIS COMPLAINT ISSUE.

    Description of Event or Problem · 0

    ALLEGEDLY, WHEN IMPLANT PACKAGE WAS OPENED, IT WAS NOTICED EVEN IF THE IMPLANT IS MARKED AS R (RIGHT SIDE) BUT ACTUALLY IT IS L (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311706 EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 10MM RIGH KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS7S10R 2022829 M684EIS7S10R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention