BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 12MM LEFT

    MDR report key: 15722546 · Received November 3, 2022

    Report

    Report Number
    3010536692-2022-00374
    Event Type
    Injury
    Date Received
    November 3, 2022
    Date of Event
    September 25, 2022
    Report Date
    November 3, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS6S12L1
    PMA / PMN Number
    K093552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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

    AFTER FURTHER ANALYSIS OF THIS EVENT FROM RELIABILITY ENGINEERING, IT HAS BEEN DETERMINED THAT THIS DEVICE SHOULD BE CONSIDERED AS NO COMPLAINT STATED SINCE THERE'S NOT AN ALLEGED DEFICIENCY AGAINST THE INSERT. IT IS IDENTIFIED THAT THE COMPLAINT IS AGAINST THE NITRIX COMPONENTS. PLEASE VOID THIS REPORT.

    Description of Event or Problem · 0

    ALLEGEDLY, REPORTER BECAME AWARE OF SOME NITRX COMPLAINTS FROM A SURGEON IN IDAHO HOWEVER, NO INFORMATION ABOUT THE COMPLAINTS WERE GIVEN TO REPORTER. MICROPORT ORTHOPEDICS VP R&D PROD. DEVELOPMENT STATED THAT HE RECEIVED A PHONE CALL FROM (B)(6) (SALES REP) SAYING THAT A DOC IN IDAHO HAD A FEW PATIENTS COME BACK IN WITH PAINFUL, SWOLLEN KNEES. HE CONTACTED THE REP TO SEE IF HE COULD GET MORE DETAILS. HE ASKED A SERIES OF QUESTIONS THAT HE DID NOT KNOW THE ANSWER. NO PART/LOT NUMBERS ARE GIVEN AND IT HAS NOT BEEN INDICATED HOW MANY EVENTS/PATIENTS HAVE OCCURRED REGARDING THESE ISSUES. ADDITIONAL INFORMATION RECEIVED ON 10/05/2022: A TOTAL OF 8 COMPLAINTS WERE RECEIVED WITH ALL RELEVANT INFORMATION INCLUDED IN EACH INCIDENT FORM. THE 7 REMAINING COMPLAINTS ARE CAPTURED UNDER DIFFERENT MICROPORT INCIDENT GROUP NUMBERS. ALLEGEDLY, RECURRING KNEE EFFUSION. NO INFECTION TO DATE. IT WAS CONFIRMED THAT EACH OF THESE PATIENTS WERE SEEN FOR FOLLOW-UP APPOINTMENTS TO ADDRESS INFLAMMATION IN THEIR KNEES. THE SURGEON CONFIRMED THAT NONE OF THE PATIENTS HAD INFECTIONS AND THAT THEIR KNEES HAD FLUID BUILDUP THAT WAS DRAINED. THE SURGEON HAS NOT BEEN ABLE TO DETERMINE IF THESE EVENTS WERE CAUSED BY AN ALLEGED DEFICIENCY/FAILURE AGAINST THESE DEVICES OR IF THEY WERE CAUSED DUE TO PATIENT CONDITIONS. IT IS INDICATED THAT THERE IS NO ACCESS TO INFORMATION REGARDING EACH PATIENT'S CONDITION, ACTIVITY LEVEL, MEDICAL HISTORY, ETC. INCIDENT FORM RECEIVED CONTAINS TWO EVOLUTION® MP CS INSERTS HOWEVER ONLY ONE INSERT (EIS6S12L) IS INDICATED AS A REVISED COMPONENT. COMPONENTS NOT REVISED: PRODUCT ID: EFSAN6PL, EVOLUTION® NITRX? FEM CS/CR NONPOR TINBN COATED SIZE 6 PRIMARY LEFT, LOT: 18450701853258, QTY:1. PRODUCT ID: ETAKN6SL, EVOLUTION® NITRX? TIB KEELED NONPOR TINBN COATED SIZE 6 PRIMARY LEFT, LOT: 1850585, QTY: 1. PRODUCT ID: KPONTP32, ADVANCE® ONLAY ALL-POLY PATELLA 32MM TRI-PEG, LOT:1745817, QTY:1. PRODUCT ID: EIS6S14L, EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 14MM LEFT, LOT: 1826291, QTY:1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2799345 EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 12MM LEFT KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS6S12L 1874080 M684EIS6S12L1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention