BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCHONDROPLASTY

    MDR report key: 7118204 · Received December 14, 2017

    Report

    Report Number
    3008812173-2017-00027
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 19, 2017
    Report Date
    February 16, 2018
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE BONE SUBSTITUTE MATERIAL WOULD NOT SET IN THE PATIENT, AS THE ARTHROSCOPY FLUIDS WERE 73.4 DEGREES FAHRENHEIT. THERE WAS A SURGICAL DELAY OF 50 MINUTES WHILE THE DOCTOR WAITED FOR THE BONE SUBSTITUTE MATERIAL TO SET. SINCE THE SURGICAL DELAY WAS OVER 30 MINUTES, THIS IS BEING HANDLED AS A SERIOUS INJURY. HOWEVER, THE MATERIAL WAS ALSO TESTED IN A WARM WATER BATH, AND THE DEVICE PERFORMED AS EXPECTED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    WHEN THE PROCEDURE IS PERFORMED ON ANATOMICAL REGIONS OF THE BODY WHERE THE TEMPERATURE IS LOWER THAN THE CORE TEMPERATURE, IT IS NOT UNCOMMON FOR THE ACCUFILL TO TAKE A LITTLE LONGER TO SET UP. THE SURGEON NO LONGER HAS ANY CONCERNS AND THE PATIENT STATUS IS NORMAL AT THIS TIME.

    Description of Event or Problem · 1

    ACCUFILL DID NOT SET UP AFTER THE SPECIFIED TIME WAITING PERIOD OF 10 MINUTES.

    Description of Event or Problem · 1

    ACCUFILL DID NOT SET UP AFTER THE SPECIFIED TIME WAITING PERIOD OF 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898861 SUBCHONDROPLASTY SCP KIT OJH ZIMMER KNEE CREATIONS, INC. N/A KC04089

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other