BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRROR

    MDR report key: 5587337 · Received April 20, 2016

    Report

    Report Number
    3006108336-2016-00003
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    February 22, 2016
    Report Date
    April 4, 2016
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    HRY
    PMA / PMN Number
    K101206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT SYSTEM INFORMATION: FEMORAL COMPONENT - CATALOG # 100417, LOT # 1208007-A, EXPIRATION DATE 05/31/017 (3 YEAR SHELF LIFE, MANUFACTURED IN 05/2014). BASE PLATE - CATALOG#100299, LOT # 1103014-AR, EXPIRATION DATE 01/31/2017 (3 YEAR SHELF LIFE, MANUFACTURED IN 01/2014). TIBIAL INSERT - CATALOG # 100335, LOT # 1211022-A, EXPIRATION DATE 02/12/16 (3 YEAR SHELF LIFE, MANUFACTURED IN 02/2013). THE MIRROR IMPLANT SYSTEM WAS REMOVED DURING CONVERSION TO TOTAL KNEE REPLACEMENT PROCEDURE AND THE IMPLANTS WERE NOT RETURNED FOR EVALUATION SINCE THE CONVERSION WAS INDEPENDENT OF THE MIRROR IMPLANT SYSTEM. EXPLANTED IMPLANT WAS NOT RETURNED.

    Description of Event or Problem · 1

    CAYENNE MEDICAL BECAME AWARE OF A CONVERSION CASE OF MIRROR PARTIAL KNEE SYSTEM TO TOTAL KNEE ARTHROPLASTY. THE PATIENT HAD AN INFECTION THAT LEAD TO CONVERSION TO A TOTAL KNEE. THE INFECTION WAS INDEPENDENT OF THE MIRROR IMPLANT SYSTEM WHICH WAS INITIALLY IMPLANTED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245480 MIRROR UNICOMPARTMENTAL KNEE ARTHROPLASTY HRY CAYENNE MEDICAL SEE SECTION H10 SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention