MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cellulitis (1768)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 15-dec-2017 from patient.This case concerns a (b)(6) year old male patient who received treatment with synvisc one and after few weeks had cellulitis in left shin and after unknown latency had gout in the toes on his left foot.No relevant concomitant medications and concurrent condition were reported.The patient also received synvisc one bilaterally in (b)(6) 2017 and in his left knee on two prior occasions.It was reported that pain was present before the injection.Patient had no concomitant treatment with immunosuppressants.Patient had no allergy history: avian proteins, feathers, or egg products.On an unknown date in (b)(6) 2017, patient received treatment with intra articular synvisc one injection, at a dose of 6 ml once (batch/ lot number and expiration date: not reported) for osteoarthritis bilaterally.On an unknown date in 2017, two or three weeks alter, the patient experienced cellulitis on his left shin requiring four rounds of ten day courses of unidentified antibiotics.Patient had a red spot on his left shin got worse and worse until finally the patient went to the doctor.Patient experienced a low grade fever on the day he finally went to the doctor for treatment of his left shin cellulitis.On an unknown date, latency unknown, patient experienced gout in the toes on his left foot, diagnosed in the last few weeks.Patient did not patient engage in activities such as jogging or tennis soon after the injection.It was reported that knee pain improved after injection.Patient had a wbc analysis.It was reported that after four rounds of antibiotics patient recovered.Patient describes himself as well-nourished with good hygiene corrective treatment: antibiotics for cellulitis in left shin; not reported for gout in the toes on his left foot outcome: recovered for both events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: important medical event for cellulitis in left shin pharmacovigilance comment: sanofi company comment dated 22-dec-2017: this case concerns a patient who received treatment with synvisc one and later experienced cellulitis of leg with fever and redness.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration.However, due to lack of information regarding medical history, concurrent condition and past drugs precludes complete medical assessment of the case.

Event Description

This unsolicited case from united states was received on 15-dec-2017 from patient.This case concerns a (b)(6) year old male patient who received treatment with synvisc one and after few weeks had cellulitis in left shin and after unknown latency had gout in the toes on his left foot; also, device malfunction was identified for the reported lot number.No relevant concomitant medications and concurrent condition were reported.The patient also received synvisc one bilaterally in (b)(6) 2017 and in his left knee on two prior occasions.It was reported that pain was present before the injection.Patient had no concomitant treatment with immunosuppressants.Patient had no allergy history: avian proteins, feathers, or egg products.On an unknown date in (b)(6) 2017, patient received treatment with intra articular synvisc one injection, at a dose of 6 ml once (batch/ lot number: 7rsl021 and expiration date: not reported) for osteoarthritis bilaterally.On an unknown date in 2017, two or three weeks alter the patient experienced cellulitis on his left shin requiring four rounds of ten day courses of unidentified antibiotics.Patient had a red spot on his left shin got worse and worse until finally the patient went to the doctor.Patient experienced a low grade fever on the day he finally went to the doctor for treatment of his left shin cellulitis.On an unknown date, latency unknown, patient experienced gout in the toes on his left foot, diagnosed in the last few weeks.Patient did not patient engage in activities such as jogging or tennis soon after the injection.It was reported that knee pain improved after injection.Patient had a wbc analysis.It was reported that after four rounds of antibiotics patient recovered.Patient describes himself as well-nourished with good hygiene corrective treatment: antibiotics for cellulitis in left shin; not reported for gout in the toes on his left foot outcome: recovered for both events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in jun-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 was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for cellulitis in left shin additional information was received on 13-feb-2018.Additional event of device malfunction was added.The ptc results were added.Lot number for synvisc one was added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated13-feb-2018: this case concerns a patient who received treatment with synvisc one and later experienced cellulitus of leg with fever and redness.A temporal relationship can be established with the product administration.Also, the concerned lot number has been identified to have malfunction by the company.Thus, the causal relationship of the events to the products cannot be excluded.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7182824
• MDR Text Key: 96994856
• Report Number: 2246315-2017-00460
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

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?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 02/13/2018
• Supplement Dates FDA Received: 02/22/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 100