BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFILL 5CC

    MDR report key: 6142320 · Received December 2, 2016

    Report

    Report Number
    3008812173-2016-00036
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 26, 2013
    Report Date
    November 7, 2016
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    MQV
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BASED ON A CLINICAL STUDY DATA REVIEW. AT THIS TIME THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT INVOLVED IN THIS COMPLAINT IS A FEMALE AGE (B)(6) AT THE TIME OF THE INITIAL SUBCHONDROPLASTY PROCEDURE. THE PATIENT HAD A HISTORY OF RIGHT KNEE UNICOMPARTMENTAL ARTHROPLASTY ON THE MEDIAL SIDE ON (B)(6) 2009. THE PATIENT REPORTEDLY DID WELL WITH THE UKA UNTIL SHE REPORTED MEDIAL PAIN IN 2012. DR. (B)(6) EVALUATED THE PATIENT AND DIAGNOSED HER WITH A TIBIAL PLATEAU STRESS FRACTURE SUBJACENT TO THE UKA. THE PATIENT UNDERWENT SUBCHONDROPLASTY ON (B)(6) 2012 AND 4 CC OF ACCUFILL WERE INJECTED INTO THE CENTRAL PORTION OF THE MEDIAL TIBIAL PLATEAU. THE PATIENT INITIALLY HAD MEDIAL UPPER SHIN PAIN WHICH RESOLVED AND THE PATIENT RETURNED TO FULL WORK DUTY. HOWEVER, DURING A FOLLOW-UP VISIT ON (B)(6) 2012, THE PATIENT REPORTED INCREASED GRINDING AND DISCOMFORT BEHIND THE KNEE CAP. THE PATIENT HAD PERSISTENT PATELLOFEMORAL PAIN THAT WAS UNRESPONSIVE TO CONSERVATIVE MANAGEMENT. DR. (B)(6) ASSESSED THIS NEW ADVERSE EVENT POST-SUBCHONDROPLASTY AS MILD, NOT RELATED TO THE ACCUFILL DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. THE PATIENT ELECTED TO UNDERGO DIAGNOSTIC ARTHROSCOPY ON (B)(6) 2013. THE DIAGNOSTIC ARTHROSCOPY REVEALED GRADE 2 CHONDROSIS OF THE PATELLAR AND TROCHLEAR SURFACES WHICH WERE MINIMALLY DEBRIDED DURING THE PROCEDURE. THE UKA COMPONENTS WERE INTACT WITH PRISTINE APPEARANCE AND THE LIGAMENTS AND LATERAL COMPARTMENT WERE INTACT. THE PATIENT WAS NOT DEEMED A CANDIDATE FOR PATELLOFEMORAL OR TOTAL KNEE ARTHROPLASTY. REHABILITATION AND VISCO SUPPLEMENTATION WERE RECOMMENDED. DR. (B)(6) CONSIDERED THE ORIGINAL PATELLOFEMORAL PAIN ADVERSE EVENT TO BE RESOLVED ON (B)(6) 2013. THE OPERATIVE NOTES FOR THE ORIGINAL SUBCHONDROPLASTY PROCEDURE WERE NOT AVAILABLE TO REVIEW FOR THIS INVESTIGATION. THERE IS NO EVIDENCE PRESENTED SUGGESTING THAT THE ORIGINAL PROCEDURE OR THE ACCUFILL IMPLANT MATERIAL HAD A DIRECT ROLE IN THE DEVELOPMENT OF THE PATIENT'S PATELLOFEMORAL SYSTEMS. THOSE SYMPTOMS MAY HAVE DEVELOPED AS A RESULT OF ONGOING DEGENERATIVE CHANGES IN THE PATIENTS KNEE.

    Description of Event or Problem · 1

    ADVERSE EVENT POSSIBLY RELATED TO PROCEDURE BUT NOT TO THE DEVICE AS PER PHYSICIAN.

    Description of Event or Problem · 1

    ADVERSE EVENT POSSIBLY RELATED TO PROCEDURE BUT NOT TO THE DEVICE AS PER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792752 ACCUFILL 5CC CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER MQV ZIMMER KNEE CREATIONS, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention