BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCHONDROPLASTY

    MDR report key: 9217786 · Received October 22, 2019

    Report

    Report Number
    3008812173-2019-00049
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    January 30, 2019
    Report Date
    March 12, 2020
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUBJECT 20-0138 OF THE SUBCHONDROPLASTY OBSERVATIONAL KNEE STUDY RECEIVED AN ACCUFILL IMPLANT DURING THE INDEX PROCEDURE ON (B)(6) 2017. THE PRE-OPERATIVE DIAGNOSIS WAS COMPLEX TEARS OF THE MEDIAL AND LATERAL MENISCUS, CHONDROMALACIA, AND INSUFFICIENCY FRACTURE OF THE TIBIA, ALL OF THE RIGHT KNEE. PRIOR TO THE INDEX PROCEDURE, THE PATIENT HAD UNDERGONE CORTICOSTEROID INJECTIONS, VISCOSUPPLEMENTATION, UNLOADER BRACING AND PHYSICAL THERAPY TO ATTEMPT TO ADDRESS THE PAIN. THE PREOPERATIVE DIAGNOSIS WAS CONFIRMED DURING THE INDEX PROCEDURE. IN ADDITION TO THE DELIVERY OF 3.2CC¿S OF ACCUFILL TO THE LOCATION OF THE TIBIAL INSUFFICIENCY FRACTURE, A PARTIAL LATERAL MENISCECTOMY AND AMNIOTIC ALLOGRAFT TISSUE INJECTION WAS PERFORMED. FOLLOWING THE PROCEDURE, THE PATIENT AWOKE SUCCESSFULLY FROM GENERAL ANESTHESIA IN STABLE CONDITION. FOLLOWING THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ADVERSE EVENT OF OSTEOARTHRITIS, BUT THE DATE OF ONSET WAS NOT REPORTED. THE CONDITION RESULTED IN A PARTIAL KNEE REPLACEMENT OF THE MEDIAL TIBIAL PLATEAU ON (B)(6) 2019. THE HEALTH CARE PROFESSIONAL REPORTED THIS EVENT WAS POSSIBLY RELATED TO THE SUBCHONDROPLASTY STUDY PROCEDURE BUT NOT RELATED THE ACCUFILL IMPLANT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, THE EVENT IS MOST LIKELY ASSOCIATED WITH THE PATIENT¿S OSTEOARTHRITIC CONDITION. THE DHR WAS UNABLE TO BE REVIEWED, AS THE LOT NUMBER FOR THE DEVICE RELATED TO THE EVENT WAS UNABLE TO BE CONFIRMED. THE DEVICE IN QUESTION REMAINS IMPLANTED IN THE PATIENT AND THEREFORE WAS NOT RETURNED FOR THE INVESTIGATION. THERE WERE NO IMAGES AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    SUBJECT 20-0138 ADVERSE EVENT OF PARTIAL KNEE REPLACEMENT AFTER SCP.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, A PATIENT UNDERWENT AN INITIAL SUBCHONDROPLASTY PROCEDURE. ON SEPTEMBER 23, 2019, ZIMMER KNEE CREATIONS BECAME AWARE OF THE ADVERSE EVENT OF OSTEOARTHRITIS WHICH RESULTED IN A PARTIAL KNEE REPLACEMENT OF THE MEDIAL TIBIAL PLATEAU THAT OCCURRED ON (B)(6) 2019. THE HEALTH CARE PROFESSIONAL ASSESSED THE EVENT AND DETERMINED IT WAS POSSIBLE RELATED TO THE SUBCHONDROPLASTY STUDY PROCEDURE AND NOT RELATED THE ACCUFILL IMPLANT. THE OPERATIVE NOTES FOR THE EVENT WERE REQUESTED FROM THE CLINICAL PROJECT LEAD. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DHR WAS UNABLE TO BE REVIEWED, AS THE LOT NUMBER FOR THE DEVICE RELATED TO THE EVENT WAS UNABLE TO BE CONFIRMED. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    SUBJECT (B)(6) ADVERSE EVENT OF PARTIAL KNEE REPLACEMENT AFTER SCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012745 SUBCHONDROPLASTY SCP KIT OJH ZIMMER KNEE CREATIONS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other