MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUFILL 5CC; CALCIUM COMPOUND BONE SUBSITUTE MATERIAL

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

The patient is a (b)(6) year old female that presented with right knee pain primarily located in the medial compartment.Lumbar x-rays demonstrated mild, multi-level djd.An mri demonstrated a subchondral insufficiency fracture in the right medial femoral condyle.The patient presented with mild, tri-compartmental osteoarthritis.The patient elected to undergo knee arthroscopy with a subchondroplasty procedure on (b)(6) 2015 to inject accufill into the insufficiency fracture noted on the mri.The patient also consented to participate in the (b)(6) study.The patient reported a pain level of 8.5/10 prior to the subchondroplasty procedure.The patient reported receiving a course of hyaluronic acid injections and using an unloader brace as conservative treatment prior to undergoing the arthroscopy with subchondroplasty.During the arthroscopy the surgeon reported icrs grade 4 cartilage changes on the lateral femoral condyle and grade 3 changes of the patella.The medial femoral condyle demonstrated grade 2 cartilage changes but also demonstrated a bone marrow lesion.The surgeon injected 4 cc of accufill material into the medial femoral condyle.During a follow-up visit on (b)(6) 2015, 5 months after the subchondroplasty procedure, the patient reported improvement in her previously reported medial knee pain.However, she reported worsening of anterior knee pain.Radiographs taken during that visit demonstrated the previously seen mild osteoarthritis without significant progression.No complications from the previous procedure were reported.The treating physician administered a corticosteroid injection to treat the knee pain that was predominantly anterior.In (b)(6) 2016 1 year after the initial procedure, the patient returned for a follow-up clinic visit.During that visit, the patient reported that her medial knee pain had returned at a "moderate" level and that she experienced intermittent knee effusions.X-rays demonstrated no change from the prior visit.The patient was recommend for a total knee arthroplasty consult.The patient elected to undergo right total knee arthroplasty on (b)(6) 2016.The operative notes for the treating surgeon documented implantation of posterior stabilizing total knee components.No description of the bone or the previous accufill injection site was provided.There was no notation of the use of bone grafts or augments required for the procedure and no complications were reported.Post-operative radiographs demonstrated the prosthesis in satisfactory position with no acute osseous complications.The surgeon performing the original subchondroplasty procedure with the accufill injection reported the tka as an adverse event during a routine monitoring visit on (b)(6) 2016.The surgeon reported the event as not related to the accufill implant or subchondroplasty procedure.Device was not returned.

Event Description

Clinical subject after receiving scp received a total knee arthroplasty.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM COMPOUND BONE SUBSITUTE MATERIAL
• 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: 5956344
• MDR Text Key: 54924810
• Report Number: 3008812173-2016-00018
• 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: Physician
• Type of Report: Initial
• 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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 61 YR