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

Lot Number 7RSL021

Device Problems Patient-Device Incompatibility (2682); Device Contamination With Biological Material (2908)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Arthralgia (2355); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 18-jan-2018 from the patient.This case concerns a female patient with unspecified age who received treatment with synvisc one injection and after few days patient could not walk and knee was 20 times more painful than the other knee; after unknown latency the patient experienced cold, after unknown latency had injection site swollen, knee injection site redness and left leg soreness all the way in my thigh, knee and calf.No relevant past drugs was reported.Patient was diabetic (type 2) and had arthritis in her knees and were bone to bone.Always had pain in the, but is probably 50% worse since.Patient did not engage in activities such as jogging or tennis soon after the injection.Patient was not allergic to avian proteins, feathers, or egg products.Concomitant medications included metformin hydrochloride (metformin) for diabetics, paroxetine hydrochloride (paxil) for anxiety, lisinopril to protect kidney, simvastatin and cortisone injection.Patient usually received cortisone injection shots in her knee but decided to try out the gel injection.On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection at the dose of 6 ml, once (lot number and expiration date: not reported) in the left knee.Patient then had synvisc-one in the other knee about a week later.Patient said the knee was 20 times more painful than the other knee.It started a week after and patient could not walk.(latency: few days).On an unknown date, patient did have a cold but no temperature with it (latency: unknown).Patient had not seen the doctor yet.On an unknown date after unknown latency the patient experienced red and swollen at injection site for days.On an unknown date after unknown latency, patient was in so much pain that she had to use crutches and her left leg had soreness all the way in her thigh, knee and calf (soreness in left leg).Patient had injections and might ride in carts now in stores.Corrective treatment: crutches for knee was 20 times more painful than the other knee; not reported for rest outcome: unknown for cold and could not walk, not yet recovered for rest of the events seriousness criteria: disability for knee was 20 times more painful than the other knee a pharmaceutical technical complaint (ptc) was initiated with (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information was received on 26-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 27-feb-2018 from the patient.Medical history, concurrent condition and concomitant medication were added.Event of injection site swollen, knee injection site redness and knee injection site redness were added with details.Clinical course updated.Text was amended accordingly.

Event Description

Based on additional information received on 18-apr-2018 from health care professional, this case was medically confirmed.Based on additional information received on 27-feb- 2018, the case previously considered as non-serious was upgraded to serious as seriousness criteria of disability was added for event knee was 20 times more painful than the other knee.This unsolicited case from united states was received on 18-jan-2018 from the patient.This case concerns a 58 years female patient who received treatment with synvisc one injection and after few days patient could not walk and knee was 20 times more painful than the other knee/bilateral knee pain; after unknown latency the patient experienced cold, after unknown latency had injection site swollen, knee injection site redness and left leg soreness all the way in my thigh, knee and calf.A device malfunction was noted in the reported lot number.No relevant past drugs was reported.Patient was diabetic (type 2) and had arthritis in her knees and were bone to bone.Always had pain in the, but is probably 50% worse since.Patient has a history of cancer, obesity, deep vein thrombosis, back pain and vitamin d deficiency.Patient did not engage in activities such as jogging or tennis soon after the injection.Patient was not allergic to avian proteins, feathers, or egg products.Concomitant medications included metformin hydrochloride (metformin) for diabetics, paroxetine hydrochloride (paxil) for anxiety, lisinopril to protect kidney, simvastatin and cortisone injection, vitamin d, paroxetine hydrochloride (paroxetine), glipizide, warfarin, alprazolam (xanax), tramadol hydrochloride (tramadol).Mother, sister and brother of the patient were diabetic.Patient's brother also had cancer.Patient was ex-smoker.Patient had been occasionally consuming alcohol for the past 11-20 years.Patient had no known drug allergy.Patient usually received cortisone injection shots in her knee but decided to try out the gel injection.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at the dose of 6 ml, once (lot number: 7rsl021 expiration date: may-2020) in the left knee.Patient then had synvisc-one in the other knee about a week later.Patient said the knee was 20 times more painful than the other knee.It started a week after and patient could not walk.(latency: few days).On an unknown date, patient did have a cold but no temperature with it (latency: unknown).Patient had not seen the doctor yet.On an unknown date after unknown latency the patient experienced red and swollen at injection site for days.On an unknown date after unknown latency, patient was in so much pain that she had to use crutches and her left leg had soreness all the way in her thigh, knee and calf (soreness in left leg).Patient had injections and might ride in carts now in stores.Corrective treatment: crutches for knee was 20 times more painful than the other knee/bilateral knee pain; not reported for rest outcome: unknown for cold and could not walk, not yet recovered for rest of the events seriousness criteria: disability for knee was 20 times more painful than the other knee/bilateral knee pain and device malfunction a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52084 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented additional information was received on 26-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 27-feb-2018 from the patient.Medical history, concurrent condition and concomitant medication were added.Case was upgraded to serious.Event of injection site swollen, knee injection site redness and knee injection site redness were added with details.Clinical course updated.Text was amended accordingly.Additional information was received on 18-apr-2018 from health care professional.Medical history, concomitant medications were added.Case was medically confirmed.Event of knee was 20 times more painful than the other knee was updated to knee was 20 times more painful than the other knee/bilateral knee pain.Additional event of device malfunction was added.Lot number updated.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated:18-apr-2018: the pharmacological plausibility of the events to the product cannot be excluded.Moreover, as the concerned lot number has been identified to have malfunction by the company, so a causal role of the drug for the occurrence of the events 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: 7368762
• MDR Text Key: 103434824
• Report Number: 2246315-2018-00366
• 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,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Patient Sequence Number: 1
• Treatment: CORTISONE(CON.); CORTISONE(CON.); GLIPIZIDE(CON.); LISINOPRIL(CON.); LISINOPRIL(CON.); METFORMIN(CON.); METFORMIN(CON.); PAROXETINE(CON.); PAXIL(CON.); PAXIL(CON.); SIMVASTATIN(CON.); SIMVASTATIN(CON.); TRAMADOL(CON.); WARFARIN(CON.); XANAX(CON.)
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 109