BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFILL

    MDR report key: 6198627 · Received December 22, 2016

    Report

    Report Number
    3008812173-2016-00043
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    September 30, 2016
    Report Date
    November 22, 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

    THE PATIENT IS A (B)(6) MALE EVALUATED BY DR. (B)(6) FOR RIGHT KNEE PAIN. 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 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 (B)(6) STUDY OF SUBCHONDROPLASTY IN THE KNEE. DURING THE PROCEDURE, DR. (B)(6) ALSO PERFORMED CHONDRAL DEBRIDEMENT AND PARTIAL MEDIAL AND LATERAL MENISCECTOMIES. GRADE 4 CHONDRAL CHANGES WERE NOTED ON THE MFC AND MTP. THE LATERAL AND PATELLOFEMORAL COMPARTMENTS SHOWED GRADE 2 CHONDRAL CHANGES. 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 3 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 1 WEEK FOLLOW-UP, THE PATIENT WAS DOING AS EXPECTED WITH NO REPORTED ISSUES. THE PATIENT REPORTED A BASELINE PAIN LEVEL OF 6.9/10 WITH SLIGHT IMPROVEMENT TO 5.9/10 AT 6 WEEKS AND IMPROVEMENT TO 1.5/10 AT 3 MONTHS AND 2.1/10 AT 6 MONTHS. THE PATIENT REPORTED A CORRESPONDING SIGNIFICANT IMPROVEMENT IN IKDC SCORES AT 3 AND 6 MONTHS. AT THE 3 MONTH CLINIC VISIT, DR. (B)(6) REPORTED THAT THE PATIENT WAS HAVING MINIMAL PAIN AND GETTING BACK TO MOST ACTIVITIES WITH LITTLE TO NO DIFFICULTY. HOWEVER, THE PATIENT DID REPORT PAIN WHEN GOING FROM STANDING FOR EXTENDED PERIODS OF TIME TO SITTING. DR. (B)(6) ATTRIBUTED THE BULK OF THE PATIENT¿S SYMPTOMS TO ONGOING OSTEOARTHRITIS. THE PATIENT ELECTED TO UNDERGO INTRA-ARTICULAR INJECTION OF MARCAINE AND KENALOG. DURING A FOLLOW-UP VISIT ON (B)(6) 2016 THE PATIENT REPORTED THE INJECTION HAD WORKED WELL TO ALLEVIATE HIS PAIN UNTIL RECENTLY BEFORE THE VISIT WHEN HIS PAIN RETUNED. THE PATIENT¿S KNEE WAS TENDER TO PALPATION OVER THE MEDIAL JOINT LINE AND THE PATIENT REPORTED MEDIAL PAIN WHEN WALKING OR STANDING. THE PATIENT RECEIVED ANOTHER INJECTION OF MARCAINE AND KENALOG AT THE (B)(6) 2016 VISIT AND WAS COUNSELED ON VISCOSUPPLEMENTATION. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2016 WITH CONTINUED PAIN SYMPTOMS. THE PATIENT REPORTED THAT HIS PAIN WAS DIFFERENT FROM BEFORE HAVING THE SUBCHONDROPLASTY PROCEDURE BUT THAT HIS RESIDUAL PAIN WAS STILL PROBLEMATIC. RADIOGRAPHS OBTAINED DURING THAT VISIT REVEALED JOINT SPACE NARROWING, SUBCHONDRAL SCLEROSIS AND MARGINAL OSTEPHYTE FORMATION PARTICULARLY IN THE MEDIAL COMPARTMENT. THE PRIOR SUBCHONDROPLASTY PROCEDURE COULD BE SEEN ON RADIOGRAPH. THERE WAS NO EVIDENCE OF BONE COLLAPSE OR AVN. AFTER COUNSELING ON TREATMENT OPTIONS WITH DR. ROBINSON, THE PATIENT ELECTED TO UNDERGO UNI-KNEE ARTHROPLASTY (UKA). THE PATIENT UNDERWENT UKA 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 UKA 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 MEDIAL COMPARTMENT OSTEOARTHRITIS. DR. (B)(6) INDICATED THE ADVERSE EVENT AS RESOLVED UPON COMPLETION OF THE UKA ON (B)(6) 2016.

    Description of Event or Problem · 1

    PATIENT RECEIVED UKA AFTER SCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848384 ACCUFILL CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER MQV ZIMMER KNEE CREATIONS, INC. N/A KC02435

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other