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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

The patient is a (b)(6) female that was originally seen in clinic by dr.(b)(6) on (b)(6) 2015.The patient presented with a 1 year history of knee pain without specific injury.The patient reported knee pain at rest of 1/10, however, the pain increased to 10/10 by evening after weight bearing during the day.The patient reported an average pain level of 5/10.The patient also reported popping/clicking in the knee with feelings of instability.The patient had no history of prior knee surgeries and had failed to respond to a prior cortisone injection and ibuprofen.The patient present with mild effusion and joint line tenderness.Knee ligaments were stable and the patient had full range of motion.There was pain surrounding the patella with patellofemoral grind.The patient also reported significant pain to palpation along the medial tibial plateau and femoral condyle.X-rays and mri obtained of the right knee revealed degenerative changes primarily in the medial compartment of the knee.Mri revealed subchondral edema in the medial femoral condyle and medial tibial plateau consistent with closed fracture.Dr.(b)(6) estimated the bone marrow lesion (bml) in the medial femoral condyle at 3.6 cubic cm in size and the medial tibial plateau bml at 4.4 cubic cm.Dr.(b)(6) and the patient discussed proceeding with a knee arthroscopy and sobchondroplasty procedure in the medial femoral condyle and medial tibial plateau.The patient also consented to participate in the zimmer biomet sponsored study prospective efficacy evaluation of sobchondroplasty for the treatment of defects associated with bone marrow lesions.The patient completed preoperative questionnaires recording pain and function scores.The patient underwent a knee arthroscopy and sobchondroplasty procedure on (b)(6) 2015.The patient underwent general anesthesia along with a femoral block and a diagnostic arthroscopy was performed first.The patellofemoral joint was found to be free of any chondral lesions.No loose bodies were identified.The lateral meniscus demonstrated fraying of the mid body of the posterior horn with a flipped fragment.The was debrided back to a stable edge.The medial compartment demonstrated grade 4 chondral changes on both the femoral condyle and tibial plateau.These correlated with the bmls identified on the preop mri.A medial meniscus tear was also identified and debrided back to a stable edge.The knee was then sucked dry of all fluid.Two accuports were then drilled under fluoroscopic guidance, one into the medial femoral condyle, the other into the medial tibial plateau at the sites correlating with the bmls identified on mri.Intra-operative fluoroscopy images captured during the procedure were available for review at the time of this investigation.Images showed the accuports appeared to be well positioned in the bone at the two sites.However, the preoperative mri was not available for review to evaluate the proximity of the accuport positions to the bml locations identified on mri.5 cc of accufill was injected into the femoral condyle and 4 cc into the tibial plateau.The arthroscope was then placed back in the knee to confirm no extravasation of the material into the joint.Orthogonal fluoroscopic views were then obtain to confirm placement of the accufill.The accuports were removed and the portals closed with sutures.The patient was discharged to home with weight-bearing as tolerated.There were no reported complications.On (b)(6) 2015 the patient returned to the clinical for a follow-up visit.The patient reported improvements in koos pain and function scores from baseline.However, the patient reported only minimal improvement in numeric pain scores.X-rays obtained at the visit demonstrated evidence of the accufill material well placed in the medial femoral condyle and tibial plateau.The patient returned to the clinic for another follow-up visit and x-rays on (b)(6) 2015.The x-rays demonstrated little change from the previous visit and the patient reported very little change in pain and function scores.The patient returned to the clinical an additional time for a 6 month follow-up clinical study visit and demonstrated continued maintenance of small improvement from baseline koos scores with no improvement in numeric pain scores from baseline and very little change from previous follow-up visits.Clinic notes from the post-operative follow-up visits were not available for this investigation.Unfortunately, no additional documentation on the patient was available to review until (b)(6) 2016 when the patient was seen by dr.(b)(6) for a preoperative visit for a scheduled total knee arthroplasty.Dr.(b)(6) cleared the patient for surgery with a diagnosis of knee osteoarthritis.Dr.(b)(6) then performed a total knee arthroplasty on the patient on (b)(6) 2016.Operative notes from dr.(b)(6) diagnosed the patient with end-stage osteoarthritis of the right knee.He noted increased joint fluid, chronic synovitis, significant cartilage loss in the medial compartment and sclerotic bone in the weight-bearing portion of the distal femur and proximal tibia.The patient was also bone on bone in the anterior compartment with increased joint fluid, synovitis and osteophytes.Dr.(b)(6) performed the tka without complication.There was no mention of any bone grafting or augments used in the procedure.Dr.(b)(6) did send the resected area of sclerotic bone from the proximal tibia to pathology for evaluation.However, he noted that the specimen appeared to be reactive sclerotic bone secondary to osteoarthritis.At the time of this investigation, results from the pathology were not available for review.No further complications or concerns were reported on the patient at this time.Post-operative imaging after the tka revealed well positioned implants.The areas of original accufill injection could still be seen on x-ray and appeared to be well incorporated with the surrounding bone.Device not returned for evaluation.

Event Description

Subject received a total knee arthroplasty a year after receiving scp.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM PHOSPHATE COMPOUND 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: 6093475
• MDR Text Key: 59723652
• Report Number: 3008812173-2016-00025
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016

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?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Weight: 82