MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Edema (1820); Headache (1880); Myalgia (2238); Joint Swelling (2356); Constipation (3274)

Event Date 11/17/2017

Event Type  Injury  

Event Description

Septic arthritis/infection right knee [septic arthritis] ([effusion (r) knee], [device malfunction], [swelling of r knee]); constipation [constipation] ; headache [headache] ; myalgia [myalgia] ; localized edema of lower extremity [edema of lower extremities] ; unable to fully bear weight [weight bearing difficulty] ; varus deformity [knee deformity].Case narrative: upon internal review on (b)(6) 2018, this case was found to be duplicate of case (b)(4).Hence all the information from this case was merged into case (b)(4) and this case was prepared for deletion.Initial information received from united states on (b)(6) 2018 regarding an unsolicited valid serious malfunction case received from a lawyer.This case involves a (b)(6) female patient who had septic arthritis/infection right knee, unable to fully bear weight (latency: 1 day), constipation, headache, myalgia, localized edema of lower extremity and varus deformity with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was noted in the reported batch number.The patient's past medical history included colonoscopy on (b)(6) 2017, hysterectomy on (b)(6) 2017, intervertebral disc degeneration, lumbar region, spondylolisthesis, shingles inside mouth and kyphosis of thoracic region.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing chronic atrial fibrillation on (b)(6) 2016, hyperlipidaemia on (b)(6) 2016, chronic hypertension on (b)(6) 2014, chronic hypothyroid on (b)(6) 2014, codeine/penicillin allergy, egg allergy, non-smoker, alcohol user, pain in right knee, osteoporosis, spondylosis, age-related osteoporosis without fracture, aortic valve sclerosis on (b)(6) 2016, chronic diastolic congestive heart failure on (b)(6) 2017, dizzy on (b)(6) 2014, dyspnea on exertion on (b)(6) 2017, hearing loss, sensorineural on (b)(6) 2018, iron deficiency anemia due to chronic blood loss on (b)(6) 2017, mitral valve insufficiency on (b)(6) 2016 and weight loss on (b)(6) 2017.On (b)(6) 2017, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection in right knee, at the dose of 6 ml (lot - 7rsl021, 31-may-2020) for unilateral primary osteoarthritis right knee.On the same, day, within hours knee was swollen and painful and black and went to emergency room where she was admitted for 5 days.On (b)(6) 2017, patient developed an infection and had arthroscopy and debridement of knee and was unable to fully bear weight (latency: 1 day).She was placed on iv antibiotics and then oral antibiotics and was not doing better.Patient complained of persistent pain in right knee.On (b)(6) 2017, patient had moderate superstellar joint effusion and subcutaneous edema.On (b)(6) 2018, patient had no effusion in knee.There was varus deformity and diffused ecchymosis present in right lower extremity (latency: unknown).There was quite a bit of guarding of right knee and range of motion is full extension to about 95 degree of flexion without any instability (latency: unknown).On an unknown date, patient had constipation and headache (latency: unknown).Ona n unknown date, patient had myalgia, localized edema of lower extremity (latency: unknown).Relevant laboratory test results included: aspiration joint - on (b)(6) 2017: cloudy dark fluid unk [sent for analysis] blood glucose (70 - 110 mg/dl) - on (b)(6) 2017: 132 mg/dl c-reactive protein (0.0 - 8.2 mg/l) - on (b)(6) 2017: 148.2 mg/l carbon dioxide (23 - 29 mmol/l) - on (b)(6) 2017: 22 mmol/l granulocyte count (1.8 - 7.7 10*3/ul) - on (b)(6) 2017: 8.7 10*3/ul then 0.05 10*3/ul granulocyte percentage (38.0 - 73.0 %) - on (b)(6) 2017: 75.2 % international normalised ratio (0.8 - 1.2 unk) - on (b)(6) 2017: 1.4 unk lymphocyte percentage (18.0 - 48.0 %) - on (b)(6) 2017: 13.3 % prothrombin time (9.0 - 12.5 second) - on (b)(6) 2017: 14.2 second red blood cell sedimentation rate (0 - 20 mm/h) - on (b)(6) 2017: 26 mm/h red cell distribution width (11.5 - 14.5 %) - on (b)(6) 2017: 15.5 % white blood cell count - on (b)(6) 2017: 52000 unk final diagnosis was device malfunction, unable to fully bear weight, septic arthritis/infection right knee, localized edema of lower extremity, myalgia, headache, varus deformity and constipation.Corrective treatment: arthroscopic irrigation, debridement, iv antibiotics, oral antibiotics for septic arthritis/infection right knee, not reported for rest of the events outcome: not recovered for septic arthritis/infection right knee; unknown for rest of the events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant, hospitalization and intervention required for septic arthritis/infection right knee.Upon internal review on (b)(6) 2018, this case was found to be duplicate of case (b)(4).Hence all the information from this case was merged into case (b)(4)and this case was prepared for deletion.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8098882
• MDR Text Key: 128194766
• Report Number: 2246315-2018-00707
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 64