BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPORT CANNULA SIDE-DELIVERY 11GA. X 120MM

    MDR report key: 13025067 · Received December 17, 2021

    Report

    Report Number
    3008812173-2021-00006
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    December 8, 2021
    Report Date
    January 14, 2022
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    MQV
    UDI-DI
    00889024205115
    PMA / PMN Number
    K190814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. RADIOGRAPHS PROVIDED IDENTIFIED A BROKEN CANNULA IMBEDDED WITHIN THE FEMORAL CONDYLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS A PORTION OF THE DEVICE REMAINS IMPLANTED AND THE REST WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE SURGEON WAS UTILIZING THE CANNULA TO INJECT THE BONE SUBSTITUTE MATERIAL DURING A RIGHT KNEE SUBCHONDROPLASTY, THE CANNULA FRACTURED AND THE TIP WAS LEFT IN THE PATIENT'S DISTAL FEMUR. THE SURGEON OPTED NOT TO REMOVE AS REMOVAL WOULD HAVE CAUSED MORE DAMAGE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932410 ACCUPORT CANNULA SIDE-DELIVERY 11GA. X 120MM FILLER, BONE MQV ZIMMER KNEE CREATIONS, INC. N/A 47858 00889024205115

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other