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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/15/2013

Event Type  No Answer Provided  

Event Description

Clinical data review patient had a total knee replacement.

Manufacturer Narrative

The patient involved with this complaint is a (b)(6) female that presented with medial knee pain.The patient had a history of bilateral hip replacements (right hip 2006, left hip (b)(6) 2012).An mri obtained on (b)(6) 2012 demonstrated a medial meniscus tear with a bone marrow lesion in the anterior central portion of the medial tibial plateau measuring 0.88cm x 1.35cm x 1.12cm.The patient consented to be enrolled in a prospective clinical study for subchondroplasty and underwent a subchondroplasty procedure on (b)(6) 2012.The operative notes were not available for this investigation.However, the clinical study case report form indicated that 4 cc of accufill material was injected into the tibial plateau and that an arthroscopy was performed at the same time.No complications were reported at the time of surgery.The patient reported a preoperative pain level of 8/10 which improved slightly to 6/10 at 1 and 6 weeks postoperatively.However, the patient reported the pain level returning to 8/10 at 3 and 6 months.This was also confirmed by the knee injury and osteoarthritis score (koos) pain component which improved from 30.6/100 points to 52.8 at 6 weeks, but worsened to 25/100 at 6 months.Similarly, the patient reported improvement in function as evidenced by the koos adl score from 35.3/100 preop to 47.1/100 at 6 weeks, but reported worsening function at 6 months with a score of 30.9/100.During the patients 6 month follow-up visit on (b)(6) 2012, the evaluating physician noted that the patient had also been recently diagnosed with ankylosing spondylitis and was placed on methotrexate.Per the study protocol, the patient also obtained a new mri on (b)(6) 2013.During a clinic visit on (b)(6) 2013, the treating physician administered a synvisc 1 injection into the study knee and evaluated the mri.The physician noted worsening chondromalacia in the patella-femoral joint, a diminutive medial meniscus posterior horn and the presence of a new region of bone marrow edema in the medial femoral condyle.The physician also described the region of the previous accufill injection in the tibial plateau as "new changes which may be consistent with some avn of the medial tibial plateau" and "new signal abnormality medial tibial plateau consistent with bone infarct/osteonecrosis." unfortunately, the mr images were unavailable for this investigation.It is important to note that post-operative imaging of accufill injected into cancellous bone is often misdiagnosed as avn or a bone infarct.Since the post-operative mri is unavailable, the presence of avn cannot be confirmed or excluded.On (b)(6) 2013, the patient returned to the clinic for a follow-up evaluation reported a knee pain level of 10/10.New radiographs were order which demonstrated severe medial osteoarthritis with joint space narrowing, osteophytes, subchondral sclerosis and subchondral cysts.Treatment options were discussed with the patient including total joint replacement.The patient elected to undergo total joint replacement on (b)(6) 2013.No operative notes were available for the total knee replacement procedure.However, clinic notes from a follow-up visit on (b)(6) 2013 indicated that the patient was doing well with no complaints of pain or discomfort.Radiographs obtained during that visit indicated a well fixed total knee implant with no evidence of complications.It is unclear from the evidence provided whether the accufill implant site failed and contributed to the ongoing knee pain in this patient or if the worsening symptoms was a result of continued progression of the pre-existing osteoarthritis in the medial compartment as evidenced by the degenerative meniscus, new bone marrow lesions in the femoral condyle and worsening of osteoarthritis in the patella-femoral joint.Operative notes documenting the status and quality of the bone at the time of revision surgery were unavailable.However, the revision surgery appeared to be successful according to the post-operative clinic notes.Device was not made available.

Event Description

Clinical data review patient had a total knee replacement.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM PHOSPHATE 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: 5773498
• MDR Text Key: 49054446
• Report Number: 3008812173-2016-00012
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

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 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: 06/06/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR