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

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

Patient Problems Loss of Range of Motion (2032); Therapeutic Response, Decreased (2271); Joint Swelling (2356); Joint Disorder (2373); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Hard to bend knees [joint range of motion decreased], hard to walk [walking difficulty], knees were inflamed/knees were swollen up [swelling of r 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 right 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 right 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 right 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 knees [joint range of motion decreased].Hard to walk [walking difficulty].Knees were inflamed/knees were swollen up [joint swelling inflammatory].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 87 years old female patient who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and it was hard to bend my knees, hard to walk, knees were inflamed/knees were swollen up, withdraw fluid from each knee and pain was back.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 hylan g-f 20, sodium hyaluronate 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 hylan g-f 20, sodium hyaluronate again.On an unknown date in 2020, the patient received hylan g-f 20, sodium hyaluronate injection (solution for injection) second time in right 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 right knee was swollen (arthritis) and it made her hard to walk (gait disturbance, event assessed as serious as it was leading to disability).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, event assessed as serious as it was leading to disability) (onset date: 2020, latency: unknown) and walk.On an unknown date in 2020, after unknown latency, doctor had to withdraw fluid from right 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 (arthritis).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.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 arthritis, joint effusion and not reported for other events.Outcome: recovered for arthritis , not applicable for therapeutic response decreased, recovering for joint range of motion decreased and gait disturbance; unknown for joint effusion.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.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-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: (b)(6) 2021.Follow up was received on 11-jan-2021 form healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 22-jan-2021 from healthcare professional.Investigational results were added.Text amended accordingly.

Event Description

Hard to bend knees [joint range of motion decreased].Hard to walk [walking difficulty].Knees were inflamed/knees were swollen up [joint swelling inflammatory].Withdraw fluid from each knee [joint effusion].Pain was back/ "hurt like mad now" [aching (r) knee].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 87 years old female patient who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and it was hard to bend my knees, hard to walk, knees were inflamed/knees were swollen up, withdraw fluid from each knee and pain was back/ "hurt like mad now".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) (18 months prior to second treatment), patient had received hylan g-f 20, sodium hyaluronate 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 hylan g-f 20, sodium hyaluronate again.Concomitant medication included: cortisone.On an unknown date in summer of 2020, the patient received hylan g-f 20, sodium hyaluronate injection (solution for injection), 48 mg second time in right knee, once (batch number, route: unknown) for pain in knee/knees started hurting due to osteoarthritis.After the second treatment, she felt just like the first time- "it was like a miracle".The injections did not hurt and patient did not even know where it went in.However, patient got off the table and did not rest: she went up and down stairs about 28 steps.Then patient went and did about 15 minutes slow on a stationary bike.The next day, on an unknown date in 2020, patient's right knee was swollen (arthritis) and it made her hard to walk (gait disturbance, event assessed as serious as it was leading to disability).Patient was sure that she had inflammation because of the stairs and walking that patient did after the injections.Patient called the doctor and went to his office the following day.Patient was taken back to the office in wheelchair because it was hard to bend knees (joint range of motion decreased, event assessed as serious as it was leading to disability) (onset date: 2020, latency: unknown) and walk.On an unknown date in 2020, after unknown latency, doctor had to withdraw fluid from the knees (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 (arthritis).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 (athralgia).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 anybody had suggested.Patient also tried braces that helped and made her knees more stable but they did not helped with the pain.She stated that her knees "hurt like mad now" (athralgia).She was eager for re-treatment as soon as possible- cortisone did not work for her.She wished she could get synvisc-one in her shoulders too, because they hurt from arthritis too.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 arthritis, joint effusion; not reported for rest of the events.Outcome: recovered for arthritis; recovering for joint range of motion decreased and gait disturbance; unknown for rest of the events.A product technical complaint (ptc) was initiated on 11-jan-2021 for synvisc one for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.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-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 22-jan-2021.Follow up was received on 11-jan-2021 form healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 22-jan-2021 from healthcare professional.Investigational results were added.Text amended accordingly.Additional information was received on 03-feb-2021 from patient via call center.Verbatim of arthralgia updated to pain was back/ "hurt like mad now".Suspect dose and indication added.Concomitant medication added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11185151
• MDR Text Key: 232816336
• Report Number: 2246315-2021-00027
• 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,Followup
• Report Date: 02/09/2021

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
• Treatment: CORTISONE (CORTISONE),
• Patient Outcome(s): Disability
• Patient Age: 87 YR