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

Lot Number UNKNOWN

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

Patient Problems Loss of Range of Motion (2032); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 08-dec-2020: this case concerns a patient who was on treatment with synvisc one and can't bend her knee for which she worse a brace, was not really be able to work as she works in retail and is on her feet a lot and was not able to walk.Although synvisc one was used for discomfort after the meniscus tear surgery which is off label indication, based upon the information, the causal role of product cannot be denied with the occurrence of events.However, lack of information regarding concomitant medications and other risk factors precludes the complete medical case assessment.

Event Description

Can't bend her knee [joint range of motion decreased].Not really be able to work as she works in retail and is on her feet a lot [impaired work ability].Not able to walk [unable to walk].Draw off 40-50mls of fluid from her knee and it comes back the next day [effusion (r) knee] ([aching (r) knee], [swelling of r knee], [off label use of device]).Case narrative: initial information received from united states on 02-dec-2020 regarding an unsolicited valid serious case received from patient.This case involves an unknown age female patient who can't bend her knee, not really be able to work as she works in retail and is on her feet a lot, not able to walk and draw off 40-50mls of fluid from her knee and it comes back the next day, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical treatment(s), vaccination(s) and family history were not provided.A year prior (2019) patient had surgery for a torn meniscus (date of torn meniscus unknown) and she had discomfort after the surgery and was receiving cortisone shots (concomitant medication).Knee was swollen and painful after the surgery.The cortisone shots were not working, and her doctor said they were going to give her a gel shot in her knee.Patient was doing research before receiving the injection and mentioned that hylan g-f 20, sodium hyaluronate was the injection that people had the worse reactions with.She did not want the hylan g-f 20, sodium hyaluronate injection and her doctor stated that he does not like to give hylan g-f 20, sodium hyaluronate but it was the only one her insurance company would pay for.On an unknown date in (b)(6) 2020 (4 weeks ago from the initial receipt date), the patient started taking hylan g-f 20, sodium hyaluronate injection (with an unknown batch number, frequency, dose) in the right knee at her orthopedic's office for discomfort after the surgery (off label use of device).Patient stated that she did not receive any instructions, she was just informed that it may take 3-4 weeks before she sees an improvement.A couple of days after receiving the injections (onset: (b)(6) 2020, latency: few days) patient's knee was sore and extremely swollen (arthralgia, joint swelling).It was reported that each time she goes to the doctor they draw off 40-50 mls of fluid from her knee and it comes back the next day (joint effusion; onset: (b)(6) 2020, latency: few days).She had to go to her doctor's office three times since receiving the injection with the last visit being wednesday ((b)(6) 2020) and her knee was swollen again on thursday ((b)(6) 2020).Since an unknown date in 2020, after unknown latency, patient has not really been able to work as she worked in retail and was on her feet a lot (impaired work ability) and she was not able to walk (gait inability).Since an unknown date in 2020, after unknown latency, patient could not bend her knee (joint range of motion decreased) and she had to wear a brace.Events of gait inability, impaired work ability and joint range of motion decreased were assessed as serious due to disability.Patient stated that when she was off she was spending most of her time at the doctor's office and her knee has not been this swollen or painful even after surgery.Action taken: not applicable for all events.Corrective treatment: brace for joint range of motion decreased, fluid drawn off for joint effusion and its symptoms, not reported for rest of the events.Outcome: unknown for all events.A product technical complaint was initiated and results were pending for the same.

Event Description

Can't bend her knee [joint range of motion decreased] not really be able to work as she works in retail and is on her feet a lot [impaired work ability] not able to walk [unable to walk] draw off 40-50mls of fluid from her knee and it comes back the next day [effusion (r) knee] ([aching (r) knee], [swelling of r knee], [off label use of device]).Case narrative: initial information received from united states on 02-dec-2020 regarding an unsolicited valid serious case received from patient.This case involves an unknown age female patient who can't bend her knee, not really be able to work as she works in retail and is on her feet a lot, not able to walk and draw off 40-50mls of fluid from her knee and it comes back the next day, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical treatment(s), vaccination(s) and family history were not provided.A year prior (2019) patient had surgery for a torn meniscus (date of torn meniscus unknown) and she had discomfort after the surgery and was receiving cortisone shots (concomitant medication).Knee was swollen and painful after the surgery.The cortisone shots were not working, and her doctor said they were going to give her a gel shot in her knee.Patient was doing research before receiving the injection and mentioned that hylan g-f 20, sodium hyaluronate was the injection that people had the worse reactions with.She did not want the hylan g-f 20, sodium hyaluronate injection and her doctor stated that he does not like to give hylan g-f 20, sodium hyaluronate but it was the only one her insurance company would pay for.On an unknown date in (b)(6) 2020 (4 weeks ago from the initial receipt date), the patient started taking hylan g-f 20, sodium hyaluronate injection (with an unknown batch number, frequency, dose) in the right knee at her orthopedic's office for discomfort after the surgery (off label use of device).Patient stated that she did not receive any instructions, she was just informed that it may take 3-4 weeks before she sees an improvement.A couple of days after receiving the injections (onset: (b)(6) 2020, latency: few days) patient's knee was sore and extremely swollen (arthralgia, joint swelling).It was reported that each time she goes to the doctor they draw off 40-50 mls of fluid from her knee and it comes back the next day (joint effusion; onset: (b)(6) 2020, latency: few days).She had to go to her doctor's office three times since receiving the injection with the last visit being wednesday ((b)(6) 2020) and her knee was swollen again on thursday ((b)(6) 2020).Since an unknown date in 2020, after unknown latency, patient has not really been able to work as she worked in retail and was on her feet a lot (impaired work ability) and she was not able to walk (gait inability).Since an unknown date in 2020, after unknown latency, patient could not bend her knee (joint range of motion decreased) and she had to wear a brace.Events of gait inability, impaired work ability and joint range of motion decreased were assessed as serious due to disability.Patient stated that when she was off she was spending most of her time at the doctor's office and her knee has not been this swollen or painful even after surgery.Action taken: not applicable for all events.Corrective treatment: brace for joint range of motion decreased, fluid drawn off for joint effusion and its symptoms, not reported for rest of the events.Outcome: unknown for all events.Product technical complaint (ptc) was initiated with global ptc number 100085763 on 02-dec-2020 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 would continuously monitor 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 final investigation complete date: 14-dec-2020.Follow up information was received on 02-dec-2020 and 09-dec-2020 (both non-significant; processed with clock start date of 02-dec-2020) from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 14-dec-2020 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: 10975460
• MDR Text Key: 220530456
• Report Number: 2246315-2020-00164
• 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: 12/16/2020

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?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORTISONE (CORTISONE),UNKNOWN; CORTISONE (CORTISONE),UNKNOWN; CORTISONE (CORTISONE),UNKNOWN
• Patient Outcome(s): Disability