BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION MP CS INSERT SIZE 8 STANDARD 12MM LEFT

    MDR report key: 9955014 · Received April 13, 2020

    Report

    Report Number
    3010536692-2020-00340
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Report Date
    July 2, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS8S12L1
    PMA / PMN Number
    K093552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED EVENT DESCRIPTION.

    Description of Event or Problem · 0

    ALLEGEDLY, WHEN THE SURGEON OPENED THE KNEE UP HE SAID THAT THE POLY HAD BECOME LOOSE AND WANTED TO KNOW THE AMOUNT OF FORCE IT WOULD TAKE TO CAUSE THIS. WHEN HE REVISED THE CASE, HE USED A 10MM POLY. COMPONENTS NOT REVISED. EVOLUTION MP FEMORAL COMPONENT EFSRN8PL 1750275; EVOLUTION MP KEELED TIBIAL BASE ETPKN8PL 1746908; ADVANCED ONLAY ALL POLY PATELLA KPONTP41 01010471651757454; ADVANCED EVOLUTION PIN PACK 3 LONG K0001288 1832553.

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE, TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY, WHEN THE SURGEON OPENED THE KNEE UP HE SAID THAT THE POLY HAD BECOME LOOSE AND WANTED TO KNOW THE AMOUNT OF FORCE IT WOULD TAKE TO CAUSE THIS. WHEN HE REVISED THE CASE, HE USED A 10MM POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419399 EVOLUTION MP CS INSERT SIZE 8 STANDARD 12MM LEFT KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS8S12L 1718470 M684EIS8S12L1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention