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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Response, Decreased (2271); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Hard to bend my knees [joint range of motion decreased], hard to walk [difficulty in walking], knees were inflamed/knees were swollen up [swelling of l knee], withdraw fluid from each knee [joint effusion], pain was back [therapeutic response decreased].Case narrative: initial information received on 11-jan-2021 regarding an unsolicited valid serious case received from a patient from united states.This case is linked to case (b)(4) (multiple device; same patient).This case involves a (b)(6) years old female patient who experienced hard to bend my knees, hard to walk, knees were inflamed/knees were swollen up, withdraw fluid from each knee and pain was back, while she used medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, vaccination(s) and family history were not provided.At the time of the event, the patient's knees were bone on bone and patient had terrible knee problems.About a year and a half or two years ago (approximately in 2019), patient had received synvisc one injections in her knees and it really helped her knees.Patient got off the table after the shots and the knee problems were gone.Everything was fantastic.About a year and half (approximately in 2020), patient's knees started hurting and patient asked the doctor if she could receive synvisc one again.On an unknown date in 2020, the patient received hylan g-f 20, sodium hyaluronate injection (solution for injection) second time in left knee, once (dose, batch number, route: unknown) for pain in knee/knees started hurting.The injections did not hurt and patient did not even know where it went in.Patient got off the table and went and walked about 28 steps (stairs).Then patient went and did about 15 minutes slow on a stationary bike.The next day, on an unknown date in 2020, patient's left knee was swollen (joint swelling) and it made her hard to walk (gait disturbance).Patient was sure that she had inflammation because of the stairs and walking that patient did after the injections.Patient went to see doctor.Patient was taken back to the office in wheelchair because it was hard to bend knees (joint range of motion decreased, onset date: 2020, latency: unknown) and walk.On an unknown date in 2020, after unknown latency, doctor had to withdraw fluid from left knee (joint effusion).The doctor told patient that nothing horrible was happening but the patient could not take hylan g-f 20, sodium hyaluronate injection again because patient's knees were inflamed.Patient read that she should not exercise for 48 hours after having the hylan g-f 20, sodium hyaluronate injection, but patient did not remember anything that anyone told her at the appointment.It was reported that inflammation went away once the doctor took the fluid out.Patient had no redness and no swelling within a day.The doctor told patient that she probably lost a lot of stuff that he had put in when he took the fluid out (couple of months ago).Now, the pain was back (therapeutic response decreased).Patient had a bone density test in 2020 (at the age of (b)(6)) and was told that patient had the bones of (b)(6) year old person.It was reported that the patient had tried all kinds of things that salve that anybody had suggested.Patient also tried braces that helped and made her knees more stable but they did not helped with the pain.No further information was provided.First time product used: no.Ptc assessment: medical.Final diagnosis was pain was back, withdraw fluid from each knee, knees were inflamed/knees were swollen up, hard to walk and hard to bend my knees.Action taken: not applicable for all events corrective treatment: brace and wheel chair for joint range of motion decreased, gait disturbance; withdraw the fluid for joint swelling and not reported for other events outcome: recovered for joint swelling, not applicable for therapeutic response decreased, recovering for joint range of motion decreased and gait disturbance; unknown for joint effusion a product technical complaint was initiated with results pending for the same.Seriousness criteria: disability for joint range of motion decreased and gait disturbance.

Event Description

Hard to bend my knees [joint range of motion decreased].Hard to walk [difficulty in walking].Knees were inflamed/knees were swollen up [swelling of l knee].Withdraw fluid from each knee [joint effusion].Pain was back [therapeutic response decreased].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a patient from united states.This case is linked to (b)(4) (multiple device; same patient).This case involves a 87 years old female patient who experienced hard to bend my knees, hard to walk, knees were inflamed/knees were swollen up, withdraw fluid from each knee and pain was back, while she used medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, vaccination(s) and family history were not provided.At the time of the event, the patient's knees were bone on bone and patient had terrible knee problems.About a year and a half or two years ago (approximately in 2019), patient had received synvisc one injections in her knees and it really helped her knees.Patient got off the table after the shots and the knee problems were gone.Everything was fantastic.About a year and half (approximately in 2020), patient's knees started hurting and patient asked the doctor if she could receive synvisc one again.On an unknown date in 2020, the patient received hylan g-f 20, sodium hyaluronate injection (solution for injection) second time in left knee, once (dose, batch number, route: unknown) for pain in knee/knees started hurting.The injections did not hurt and patient did not even know where it went in.Patient got off the table and went and walked about 28 steps (stairs).Then patient went and did about 15 minutes slow on a stationary bike.The next day, on an unknown date in 2020, patient's left knee was swollen (joint swelling) and it made her hard to walk (gait disturbance).Patient was sure that she had inflammation because of the stairs and walking that patient did after the injections.Patient went to see doctor.Patient was taken back to the office in wheelchair because it was hard to bend knees (joint range of motion decreased, onset date: 2020, latency: unknown) and walk.On an unknown date in 2020, after unknown latency, doctor had to withdraw fluid from left knee (joint effusion).The doctor told patient that nothing horrible was happening but the patient could not take hylan g-f 20, sodium hyaluronate injection again because patient's knees were inflamed.Patient read that she should not exercise for 48 hours after having the hylan g-f 20, sodium hyaluronate injection, but patient did not remember anything that anyone told her at the appointment.It was reported that inflammation went away once the doctor took the fluid out.Patient had no redness and no swelling within a day.The doctor told patient that she probably lost a lot of stuff that he had put in when he took the fluid out (couple of months ago).Now, the pain was back (therapeutic response decreased).Patient had a bone density test in 2020 (at the age of 86) and was told that patient had the bones of 65 year old person.It was reported that the patient had tried all kinds of things that salve that anybody had suggested.Patient also tried braces that helped and made her knees more stable but they did not helped with the pain.No further information was provided.First time product used: no.Ptc assessment: medical.Final diagnosis was pain was back, withdraw fluid from each knee, knees were inflamed/knees were swollen up, hard to walk and hard to bend my knees.Action taken: not applicable for all events.Corrective treatment: brace and wheel chair for joint range of motion decreased, gait disturbance; withdraw the fluid for joint swelling and not reported for other events outcome: recovered for joint swelling, not applicable for therapeutic response decreased, recovering for joint range of motion decreased and gait disturbance; unknown for joint effusion product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number; unknown, device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance report) 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 will continue to monitor adverse events to determine if a capa is required final investigation complete date: (b)(6) 2021.Seriousness criteria: disability for joint range of motion decreased and gait disturbance additional information was received on 11-jan-2021 and 19-jan-2021 (processed together with csd of 19-jan-2021) from healthcare professional.Global ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11184114
• MDR Text Key: 232815457
• Report Number: 2246315-2021-00026
• 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
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 87 YR