BEUDAMED
    FDA Adverse Event Summary report: N

    ACCUFILL

    MDR report key: 6193372 · Received December 21, 2016

    Report

    Report Number
    3008812173-2016-00042
    Date Received
    December 21, 2016
    Date of Event
    September 16, 2016
    Report Date
    November 29, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS A (B)(6) MALE EVALUATED BY DR. (B)(6) FOR RIGHT KNEE PAIN ASSOCIATED WITH A WORKMAN'S COMPENSATION CLAIM FOR A WORK INJURY. THE PATIENT WAS DIAGNOSED WITH RIGHT KNEE ARTHRITIS WITH DEGENERATIVE MEDIAL AND LATERAL MENISCUS TEARS AND INSUFFICIENCY FRACTURES OF THE MEDIAL FEMORAL CONDYLE (MFC) AND MEDIAL TIBIAL PLATEAU (MTP). THE PATIENT HAD FAILED TO RESPOND TO CORTICOSTEROID INJECTIONS, UNLOADER BRACE AND CRUTCHES. THE PATIENT ELECTED TO UNDERGO SUBCHONDROPLASTY TO TREAT THE INSUFFICIENCY FRACTURES AND ARTHROSCOPY PERFORMED BY DR. (B)(6) ON (B)(6) 2016. THE PATIENT WAS ALSO ENROLLED IN THE OBSERVATIONAL COHORT STUDY OF SUBCHONDROPLASTY IN THE KNEE. DURING THE PROCEDURE, DR. (B)(6) ALSO PERFORMED CHONDRAL DEBRIDEMENT, PARTIAL MEDIAL AND LATERAL MENISCECTOMIES AND REMOVAL OF A LARGE LOOSE BODY. GRADE 4 CHONDRAL CHANGES WERE NOTED IN ALL THREE COMPARTMENTS OF THE KNEE. ACCUPORT CANNULAS WERE PLACED UNDER FLUOROSCOPIC GUIDANCE IN THE PROXIMITY OF THE INSUFFICIENCY FRACTURES OF THE MFC AND MTP. FRACTURE STABILIZATION WAS THEN PERFORMED BY INJECTING 3 CC OF ACCUFILL INTO THE MFC AND 7 CC INTO THE MTP. FILL WAS MONITORED USING FLUOROSCOPY AND THE ACCUFILL WAS ALLOWED TO HARDEN BEFORE REMOVAL OF THE CANNULAS. THE ARTHROSCOPE WAS THEN PLACED BACK IN THE KNEE TO CONFIRM THAT NO ACCUFILL MATERIAL WAS PRESENT INSIDE THE JOINT. AT 2 WEEK FOLLOW-UP, THE PATIENT WAS DOING AS EXPECTED WITH NO REPORTED ISSUES. THE PATIENT REPORTED ONLY A SLIGHT IMPROVEMENT IN PAIN OVER BASELINE AT 6 WEEKS AND 3 MONTHS WITH A CORRESPONDING SMALL IMPROVEMENT IN IKDC AND SF-12 PHYSICAL COMPONENT SCORES. AT THE 3 MONTH CLINIC VISIT, DR. (B)(6) REPORTED THAT THE PATIENT WAS HAVING SLIGHTLY MORE PAIN THAT HE WOULD LIKE AND PROCEEDED TO INJECT THE PATIENT WITH MARCAINE AND KENALOG. AT 4 MONTHS THE PATIENT WAS STILL COMPLAINING OF MODERATE PAIN, POTENTIALLY EXACERBATED BY A RECENT PHYSICAL THERAPY VISIT. RADIOGRAPHS OBTAINED AT THE 4 MONTH VISIT SHOWED THE ACCUFILL IN THE APPROPRIATE POSITIONS. HOWEVER, THE RADIOGRAPHS CONTINUED TO DEMONSTRATE SIGNIFICANT TRI-COMPARTMENTAL OSTEOARTHRITIS WITH JOINT SPACE NARROWING, SUBCHONDRAL SCLEROSIS AND OSTEOPHYTE FORMATION. DR. (B)(6) RECOMMENDED VISCO SUPPLEMENTATION FOR THE PATIENT TO CONSIDER. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2016 WITH CONTINUED PAIN SYMPTOMS. AFTER COUNSELING ON TREATMENT OPTIONS WITH DR. (B)(6), THE PATIENT ELECTED TO UNDERGO TOTAL KNEE ARTHROPLASTY (TKA). THE PATIENT UNDERWENT TKA ON (B)(6) 2016, PERFORMED BY DR. (B)(6). IN DOCUMENTING THE TKA, DR. (B)(6) MADE NO COMMENT ON THE ACCUFILL INJECTION SITES. ALL BONE CUTS FOR THE PROCEDURE APPEARED TO BE PERFORMED AS PLANNED, THERE WAS NO MENTION OF AUGMENTS NOR BONE GRAFTS USED AND NO INTRA-OPERATIVE COMPLICATIONS OR ISSUES WERE DESCRIBED. DR. (B)(6) REPORTED THE TKA ON A SERIOUS ADVERSE EVENT CASE REPORT FORM AS PART OF THE REQUIREMENTS FOR THE CLINICAL STUDY. THE AE WAS DESCRIBED AS INCREASED PAIN DUE TO OSTEOARTHRITIS. ON THE FORM, DR. (B)(6) EVALUATED THE EVENT AS SEVERE, BUT NOT RELATED TO THE SUBCHONDROPLASTY PROCEDURE AND NOT RELATED TO THE DEVICE. THE EVENT APPEARS TO BE MOST RELATED TO THE PATIENTS PRE-EXISTING TRI-COMPARTMENTAL OSTEOARTHRITIS. DR. (B)(6) INDICATED THE ADVERSE EVENT AS RESOLVED UPON COMPLETION OF THE TKA ON (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THE NATURE OF THIS COMPLAINT IS FROM A RETROSPECTIVE CLINICAL STUDY DATA REVIEW. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    SUBJECT OF CLINICAL STUDY RECEIVED TKA AFTER SCP.

    Description of Event or Problem · 1

    SUBJECT OF CLINICAL STUDY RECEIVED TKA AFTER SCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842454 ACCUFILL CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER MQV ZIMMER KNEE CREATIONS, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other