MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUFILL 5CC; BONE VOID FILLER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

At this time the investigation of this clinical study subject is still in-progress.A follow up mdr will follow this mdr as soon as the investigation and root cause are identified.Device not available.

Event Description

Clinical study subject received a total knee arthroplasty after scp.

Manufacturer Narrative

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 prior knee arthroscopy with partial medial meniscectomy and chondral debridement on (b)(6) 2010.The patient was evaluated by dr.(b)(6) in his office and was diagnosed with arthritis of the knee with a bone marrow lesion consistent with insufficiency fracture in the medial tibial plateau.The patient weighed (b)(6) with a bmi of 40.The patient had failed to respond to conservative treatments and elected to proceed with a subchondroplasty procedure to treat the insufficiency fracture and knee arthroscopy.The procedure was performed by dr.(b)(6) on (b)(6) 2015.The patient underwent general anesthesia along with a regional nerve block and a tourniquet was inflated at the start of the procedure.The arthroscopy was performed first.The patient's acl and pcl were intact.The patient's medial femoral condyle and medial tibial plateau both demonstrated grade 4 chondral changes.There were significant loose chondral fragments that were debrided with an arthroscopic shaver.No significant medial meniscus tears were identified requiring resection.The lateral femoral condyle showed grade 2 changes and the lateral tibial plateau grade 3 changes.Significant lateral meniscus tears were identified and debrided.The patellofemoral showed grade 3 chondral changes.Additional loose chondral fragments were debrided throughout the knee.Arthroscopic instruments were then removed and the subchondroplasty portion of the procedure was started.An accuport cannula was placed under fluoroscopic guidance into the medial tibial plateau using the preoperative mri to approximate the location of the insufficiency fracture.Fluoroscopy was then used to monitor the injection of 4 cc of accufill material through the cannula into the location of the subchondral bone lesion.The trochar was then reinserted and the accufill allowed to harden prior to removal of the cannula.The arthroscope was then placed back into the joint, and the joint was carefully inspected to ensure no accufill material was in the joint space.The procedure was then completed and surgical wounds closed.No complications were reported with the procedure.The patient was also enrolled in the (b)(6) clinical study.The patient reported a preoperative pain level of 9/10 and a preoperative ikdc score of 19 indicating significant pain and disability.At 6 weeks the patient reported improvement in pain to 1/10 with a pain level of 3/10 reported at 3 months.However the patients pain level gradually worsened to 5/10 at six months and 8/10 at 1 year after the procedure.The patients ikdc scores also improved to 29 at 6 weeks, 33 at 3 months and 39 at 6 months but then worsened to 24 at 1 year.Notes from follow-up clinic visits indicated that the patient initially progressed as expected at 1 week and 4 weeks with minimal pain and numbness in the shin.At six weeks the patient reported minimal pain over the tibia.At 12 weeks the patient reported only mild discomfort with participation in activities as planned.The patient complained of re-aggravation of a pre-existing back condition.A kenalog injection was performed into the knee during that visit.At 4 months the patient reported a moderate amount of pain and that the previous kenalog injection had only provide relief of symptoms for a day.The patient reported having some difficulty with stairs and had some swelling of the knee.X-rays obtained during that visit showed evidence of the previous subchondroplasty with no evidence of fracture or dislocation and continued evidence of tri-compartmental osteoarthritis.During a follow-up visit on (b)(6) 2016, the patient reported continued pain in the medial compartment and was given an injection of synvisc one.During a clinic visit on (b)(6) 2016, the patient reported that the viscosupplementation injection had not worked as she hoped and had continued pain with standing, climbing stairs and driving.At that point she reported that her pain was throughout the entire knee.The patient elected to try bracing for her knee and the potential for future total knee arthroplasty was discussed.During a follow-up visit on (b)(6) 2016, the patient was reporting a pain level between 7/10 and 10/10.The patient had returned to pain management and was trying anti-inflammatory medications.Dr.(b)(6) discussed with the patient that they had exhausted all conservative therapy options and the patient agreed that the next step was total knee arthroplasty.On (b)(6) 2016, dr.(b)(6) performed an elective total knee arthroplasty on the patient for a diagnosis of right knee osteoarthritis.The procedure was performed without complication with no mention of bone grafts, augments or additional unplanned fixation required.The condition of the prior accufill injection site was not described in the operative notes.At 1 month following the tka, the patient appeared to be progressing as expected.Dr.(b)(6) reported the progression of the degenerative arthritis resulting in a tka as an adverse event as part of the (b)(6) study.In documenting the ae, dr.(b)(6) indicated that the event was not related to the device or the procedure.

Event Description

Clinical study subject received a total knee arthroplasty after scp.

• Brand Name: ACCUFILL 5CC
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: victor krone ; 841 springdale drive; exton, PA 19341 ; 4848794224
• MDR Report Key: 6031128
• MDR Text Key: 57493332
• Report Number: 3008812173-2016-00022
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 201.050
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 104