BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCHONDROPLASTY

    MDR report key: 7933712 · Received October 4, 2018

    Report

    Report Number
    3008812173-2018-00036
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    August 13, 2018
    Report Date
    October 12, 2018
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT APPROXIMATELY 1CC OF ACCUFILL EXTRAVASATED INTO THE JOINT DUE TO CORTICAL PERFORATION WHEN THE CANNULA WAS INTRODUCED. DURING THE PROCEDURE ON (B)(6) 2018, THE SURGEON PERFORATED THE CONTRALATERAL CORTICAL WALL WHICH, DURING THE ACCUFILL INJECTION STEP OF THE SCP PROCEDURE, WAS THE SOURCE OF EXTRAVASATION. THE EXTRAVASATED ACCUFILL WAS IDENTIFIED AND REMOVED PER STANDARD SURGICAL TECHNIQUE. THE PROCEDURE PROCEEDED AS ANTICIPATED AND THE PATIENT REMAINS IN THE CLINICAL COHORT.

    Description of Event or Problem · 0

    ACCUFILL EXTRAVASATED INTO THE JOINT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT APPROXIMATELY 1CC OF ACCUFILL EXTRAVASATED INTO THE JOINT DUE TO CORTICAL PERFORATION WHEN THE CANNULA WAS INTRODUCED. THE ACCUFILL WAS EVACUATED AND IRRIGATED. THE PATIENT WAS AWOKEN FROM ANESTHESIA AND TAKEN BACK TO RECOVERY IN STABLE CONDITION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCUFILL EXTRAVASATED INTO THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775859 SUBCHONDROPLASTY SCP KIT OJH ZIMMER KNEE CREATIONS, INC. N/A KC04571

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR