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

Lot Number 7RSL021

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arthritis (1723); Fever (1858); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Joint Disorder (2373); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on (b)(6) 2018 from the patient this case concerns a (b)(6) years old female patient who initiated treatment with synvisc one and after few hours could barely get into her house/could walk very short distances/could not walk very far without pain, had inflammation; and on the same day had fever; after unknown latency had stiffness in the knees no previous medications, concomitant medications and concurrent conditions were reported.Patient was not allergic to avian proteins, feathers, or egg products.Patient did not have prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator.On (b)(6) 2017, at 9:30, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (indication: not provided; batch/ lot number and expiry date: unknown) for osteoarthritis in both knees.On the same day, after a few hours, at around 04:00 pm she could barely get into her house.She said the physician told her to elevate and ice the knees.She said to take aleve qd for pain and inflammation.She said the pain and swelling in both knees started about the same time that day.She said she had to use canes to get around in the house.She said, the next day, (b)(6) 2017, she could not tolerate the pain and swelling.She said she stayed in bed the whole weekend or go to work.She said she called the physician that day and her prescribed a prednisone taper packet to take for several days.She said the first few days she experienced fever and chills.On (b)(6) 2017, the swelling and pain went down a little bit and the medication helps some.On the same day, she went back the physician and he drew fluid out of her right knee only.She said the physician told her to stay on the prednisone taper, elevate, and apply ice to both knees.She said she could get around some on (b)(6) 2017.She said she could get around some on monday.She said she could walk very short distances which continued for another week.She said, after the 2 weeks, her pain and swelling was better but she noticed she still could not walk very far without pain and the knees did not bend or straighten completely.She said sometimes she would substitute for the aleve with an ibuprofen or acetaminophen but not at the same time.She said her personal trainer is working with her on the stiffness in the knees there is improvement but she is not back to how she was prior to the synvisc one injections.She said she did not know the lot numbers or expiration dates for the synvisc-one syringes.Corrective treatment: use canes could barely get into her house/could walk very short distances/could not walk very far without pain; prednisone taper, naproxen sodium (aleve), elevate, and apply ice to both knees for inflammation, stiffness in the knees; not reported for fever.Outcome: recovering for fever; not recovered for rest of the events seriousness criteria: disability for could barely get into her house/could walk very short distances/could not walk very far without pain; required intervention for stiffness in the knees and inflammation.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who received synvisc one injection and later had difficulty in walking for which patient used canes.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history and other risk factors precludes the complete medical case assessment.

Event Description

This spontaneous case from united states was received on 12-jan-2018 from the patient this case concerns a (b)(6) female patient who initiated treatment with synvisc one and after few hours could barely get into her house/could walk very short distances/could not walk very far without pain, had inflammation; and on the same day had fever; after unknown latency had stiffness in the knees no previous medications, concomitant medications and concurrent conditions were reported.Patient was not allergic to avian proteins, feathers, or egg products.Patient did not have prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator.On (b)(6) 2017, at 9:30, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (indication: not provided; batch/ lot number and expiry date: unknown) for osteoarthritis in both knees.On the same day, after a few hours, at around 04:00 pm she could barely get into her house.She said the physician told her to elevate and ice the knees.She said to take aleve qd for pain and inflammation.She said the pain and swelling in both knees started about the same time that day.She said she had to use canes to get around in the house.She said, the next day, (b)(6) 2017, she could not tolerate the pain and swelling.She said she stayed in bed the whole weekend or go to work.She said she called the physician that day and her prescribed a prednisone taper packet to take for several days.She said the first few days she experienced fever and chills.On (b)(6) 2017, the swelling and pain went down a little bit and the medication helps some.On the same day, she went back the physician and he drew fluid out of her right knee only.She said the physician told her to stay on the prednisone taper, elevate, and apply ice to both knees.She said she could get around some on (b)(6) 2017.She said she could get around some on monday.She said she could walk very short distances which continued for another week.She said, after the 2 weeks, her pain and swelling was better but she noticed she still could not walk very far without pain and the knees did not bend or straighten completely.She said sometimes she would substitute for the aleve with an ibuprofen or acetaminophen but not at the same time.She said her personal trainer is working with her on the stiffness in the knees there is improvement but she is not back to how she was prior to the synvisc one injections.She said she did not know the lot numbers or expiration dates for the synvisc-one syringes.Corrective treatment: use canes could barely get into her house/could walk very short distances/could not walk very far without pain; prednisone taper, naproxen sodium (aleve), elevate, and apply ice to both knees for inflammation, stiffness in the knees; not reported for fever.Outcome: recovering for fever; not recovered for rest of the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51970 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.Seriousness criteria: disability for could barely get into her house/could walk very short distances/could not walk very far without pain; required intervention for stiffness in the knees and inflammation follow up was received on 17-jan-2018.No new information was received.Additional information was received on 03-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 3-feb-2018: follow up information did not change the previous case assessment.This case concerns a patient who received synvisc one injection and later had difficulty in walking for which patient used canes.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history and other risk factors precludes the complete medical case assessment.

Event Description

This spontaneous case from united states was received on 12-jan-2018 from the patient.This case concerns a (b)(6) years old female patient who initiated treatment with synvisc one and after few hours could barely get into her house/could walk very short distances/could not walk very far without pain/ barely able to walk, had inflammation; and on the same day had fever and standing up was the worst; after unknown latency had stiffness in the knees/ both knees are stiff.Also, device malfunction was identified for the reported lot number no medical history was reported.Patient was not allergic to avian proteins, feathers, or egg products.Patient did not have prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator.Concomitant medications included hydrochlorothiazide/losartan potassium (hyzaar) for hypertension and zoloft for anxiety.On (b)(6) 2017, at 9:30, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: 31-may-2020) for osteoarthritis in both knees.On the same day, after a few hours, at around 04:00 pm she could barely get into her house.She said the physician told her to elevate and ice the knees.She said to take aleve qd for pain and inflammation.She said the pain and swelling in both knees started about the same time that day.She said she had to use canes to get around in the house.The same day, after the injection on both knees, they become very painful, stiff, swollen and sensitive.The patient was barely able to walk in to the from the car and needed 2 canes to get around.Standing up was the worst, nearly unbearable, even with the help.As corrective treatment patient had cortisone and drainage in the right knee.She said, the next day, (b)(6) 2017, she could not tolerate the pain and swelling.She said she stayed in bed the whole weekend or go to work.She said she called the physician that day and her prescribed a prednisone taper packet to take for several days.She said the first few days she experienced fever and chills.On (b)(6) 2017, patient in person consulted a health professional.On (b)(6) 2017, the swelling and pain went down a little bit and the medication helps some.On the same day, she went back the physician and he drew fluid out of her right knee only.She said the physician told her to stay on the prednisone taper, elevate, and apply ice to both knees.She said she could get around some on (b)(6) 2017.She said she could get around some on monday.She said she could walk very short distances which continued for another week.She said, after the 2 weeks, her pain and swelling was better but she noticed she still could not walk very far without pain and the knees did not bend or straighten completely.She said sometimes she would substitute for the aleve with an ibuprofen or acetaminophen but not at the same time.She said her personal trainer is working with her on the stiffness in the knees there is improvement but she is not back to how she was prior to the synvisc one injections.On unknown dates, the patient recovered from barely able to walk, standing up was the worst and both knees were stiff.Corrective treatment: use canes could barely get into her house/could walk very short distances/could not walk very far without pain/ barely able to walk; prednisone taper, naproxen sodium (aleve), elevate, and apply ice to both knees for inflammation and prednisone taper, naproxen sodium (aleve), elevate, and apply ice to both knees and cortisone stiffness in the knees/ both knees are stiff; cortisone for standing up was the worst; not reported for fever.Outcome: recovered/ resolved for stiffness in the knees/ both knees are stiff and could barely get into her house/could walk very short distances/could not walk very far without pain/ barely able to walk, standing up was the worst; recovering for fever; not recovered for rest of the 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 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: disability for could barely get into her house/could walk very short distances/could not walk very far without pain/ barely able to walk; required intervention for stiffness in the knees/ both knees are stiff and inflammation and standing up was the worst follow up was received on 17-jan-2018.No new information was received.Additional information was received on 03-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 12-feb-2018 from a patient.Lot number and expiration date for synvisc one were added.Event term stiffness in the knees was updated to stiffness in the knees/ both knees were stiff and its outcome was updated as recovered/ resolved and additional corrective treatment was also added.Event term could barely get into her house/could walk very short distances/could not walk very far without pain was updated as could barely get into her house/could walk very short distances/could not walk very far without pain/ barely able to walk and its outcome was updated as recovered/ resolved.Additional event standing up was the worst along with details was added.Concomitant medications and concurrent conditions were added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 12-feb-2018 this case concerns a patient who received synvisc one injection from the recalled lot and later had difficulty in walking for which patient used canes and standing up became worst.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, 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: 7230110
• MDR Text Key: 98631782
• Report Number: 2246315-2018-00170
• 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,Followup
• Report Date: 01/12/2018

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 Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 02/03/2018; 02/12/2018
• Supplement Dates FDA Received: 02/19/2018; 02/21/2018
• Patient Sequence Number: 1
• Treatment: HYZAAR(CON.); ZOLOFT(CON.)-START
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 100