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 Inflammation (1932); Ambulation Difficulties (2544)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 22-may-2023: this case involves a 65 years old male patient who reported not able to walk, fluid removed (right knee), around 60ml fluid was removed and there was no real effect with no reported adverse event while being treated with with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Not able to walk [unable to walk].Fluid removed (right knee) [arthrocentesis].Around 110ml fluid was removed [injection site joint effusion] ([injection site joint warmth], [injection site joint swelling]).There was no real effect with no reported adverse event [therapeutic product effect incomplete].Case narrative: this case is linked to case id (b)(4) (multiple device suspect used for the same patient).Initial information received on 16-may-2023 from canada regarding an unsolicited valid serious case received from the patient.This case involves a 65 years old male patient who reported not able to walk, fluid removed (right knee), around 110ml fluid was removed and there was no real effect with no reported adverse event while being treated with with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s) and family history were not provided.Concomitant medications included cortisone.On an unknown date in (b)(6)2022, the patient received synvisc one injection in his right knee at a dose 6 ml once via intra-articular route (lot, expiry date, strength - unknown) for osteoarthritis.Information on batch number was requested.Patient went to the hospital to had fluid removed on (b)(6)2023 after a latency of same day (arthrocentesis, intervention required and medically significant) around 110ml was removed (injection site joint effusion, seriousness criteria: intervention required), however was still quite swollen.He liked the product but felt he was not compatible with it and taking celebrex to control it and there was no real effect back then (therapeutic product effect incomplete).After a latency of a day or two later (onset: (b)(6)2022) patient reported his knee became hot (injection site joint warmth, seriousness criteria: intervention required), very swollen (injection site joint swelling, seriousness criteria: intervention required) to the point that he was not able to walk (gait inability, seriousness criteria: disability and intervention required).The patient was treated with celebrex for injection site joint effusion and removal of fluid for arthrocentesis and gait disturbance.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Not able to walk [unable to walk] fluid removed (right knee)/had 110 ml of synovial fluid removed [arthrocentesis] around 110ml fluid was removed [injection site joint effusion] ([injection site joint warmth], [injection site joint swelling], [injection site joint inflammation]) there was no real effect with no reported adverse event [therapeutic product effect incomplete] case narrative: this case is linked to case id (b)(4) (multiple device suspect used for the same patient) initial information received on 16-may-2023 from canada regarding an unsolicited valid serious case received from the patient.This case involves a 65 years old male patient who reported not able to walk, fluid removed (right knee), around 110ml fluid was removed and there was no real effect with no reported adverse event while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s) and family history were not provided.Concomitant medications included hyaluronic acid (durolane), viscosupplements (joint lubricant) in the previous 15 years twice per year and ''novavisc'' on (b)(6) 2022, the patient received synvisc one injection in his right knee at a dose 6 ml once via intra-articular route (lot, expiry date, strength - unknown) for osteoarthritis.Information on batch number was requested.Patient went to the hospital to had fluid removed on 04-nov-2022 after a latency of same day (arthrocentesis, intervention required and medically significant) around 110ml was removed (injection site joint effusion, seriousness criteria: intervention required), however was still quite swollen.He liked the product but felt he was not compatible with it and taking celebrex to control it and there was no real effect back then (therapeutic product effect incomplete).After a latency of a day or two later (onset: nov-2022) patient reported his knee became hot (injection site joint warmth, seriousness criteria: intervention required), very swollen (injection site joint swelling, seriousness criteria: intervention required) to the point that he was not able to walk (gait inability, seriousness criteria: disability and intervention required).Patient used to receive other viscosupplements (joint lubricant) in the previous 15 years twice per year.He received durolane and ''novavisc'' and did not have any problems.But because the volume injected was 3 ml and 4 ml, patient felt that it was probably not enough.So patient decided to receive synvisc-one injection.He received the injection on 04-nov-2022 and he had the same type of inflammation(injection site joint inflammation, seriousness criteria: intervention required) (onset: nov-2022) experienced in may 2023.Patient said it was really terrible, he had to rent crutches to be able to go to the er and had 110 ml of synovial fluid removed.At that time, he thought it was because he worked on his knees, that aggravated the situation.The inflammation started within 5-7 days following the injection and lasted around 1-1.5 month.Patient does not have the lot number but he said he bought the 2 boxes together (for injections of nov 2022 and may 2023).No information provided on other corrective treatment.Patient did not have any previous knee surgery, but he plans to have a knee surgery in the future.He aims to extend the time before having the surgery as much as possible with the visco supplement injections (as per his orthopedist, he will have limits after the surgery, so the orthopedist advised him to wait until the pain from osteoarthritis becomes inconceivable).Patient feels he becomes more and more reactive to synvisc-one injections.Patient has no known allergies and was not allergic to eggs.The patient was treated with celebrex for injection site joint effusion and removal of fluid for arthrocentesis and gait disturbance.Outcome: unknown for all the event additional information was received on 30-may-2023 from patient: patient medical history updated; concomitant added; drug start date added; event of injection site joint inflammation added; text amended a product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 30-may-2023: this case involves a 65 years old male patient who reported not able to walk, fluid removed (right knee), around 60ml fluid was removed and there was no real effect with no reported adverse event while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Not able to walk [unable to walk].Fluid removed (right knee)/had 110 ml of synovial fluid removed [arthrocentesis].Inflammation [injection site joint inflammation] ([injection site joint effusion], [injection site joint swelling], [injection site joint warmth]).There was no real effect with no reported adverse event [device ineffective].Case narrative: this case is linked to case id (b)(4) (multiple device suspect used for the same patient).Initial information received on 16-may-2023 from canada regarding an unsolicited valid serious case received from the patient.This case involves a 65 years old male patient who reported not able to walk, fluid removed (right knee), around 110ml fluid was removed and there was no real effect with no reported adverse event while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s) and family history were not provided.Patient has no known allergies and was not allergic to eggs.Patient used to receive other viscosupplements (joint lubricant) in the previous 15 years twice per year.He received durolane and ''novavisc'' and did not have any problems.But because the volume injected was 3 ml and 4 ml, patient felt that it was probably not enough.So patient decided to receive synvisc-one injection.Concomitant medications included hyaluronic acid (durolane), viscosupplements (joint lubricant) in the previous 15 years twice per year and ''novavisc'.' on (b)(6) 2022, the patient received synvisc one injection in his right knee at a dose 6 ml once via intra-articular route (lot, expiry date- unknown, strength: 48 mg/6ml) for osteoarthritis.Information on batch number was requested.He received the injection on (b)(6) 2022 and he had the same type of inflammation (injection site joint inflammation, seriousness criteria: intervention required) (onset: (b)(6) 2022) as experienced in (b)(6) 2023.After a latency of a day or two later (onset: (b)(6) 2022) patient reported his knee became hot (injection site joint warmth, seriousness criteria: intervention required), very swollen (injection site joint swelling, seriousness criteria: intervention required) to the point that he was not able to walk (gait inability, seriousness criteria: disability and intervention required).The inflammation started within 5-7 days following the injection.Patient said it was really terrible, he had to rent crutches to be able to go to the er.On an unknown date in (b)(6) 2022, after latency of few days, had around 110 ml of synovial fluid removed (arthrocentesis, injection site joint effusion, intervention required and medically significant), however was still quite swollen.At that time, he thought it was because he worked on his knees, that aggravated the situation.The inflammation lasted around 1-1.5 month.Patient does not have the lot number but he said he bought the 2 boxes together (for injections of nov 2022 and may 2023).He liked the product but felt he was not compatible with it and taking celebrex to control it and there was no real effect back then (device ineffective).No information provided on other corrective treatment.Patient did not have any previous knee surgery, but he plans to have a knee surgery in the future.He aims to extend the time before having the surgery as much as possible with the visco supplement injections (as per his orthopedist, he will have limits after the surgery, so the orthopedist advised him to wait until the pain from osteoarthritis becomes inconceivable).Patient feels he becomes more and more reactive to synvisc-one injections.The patient was treated with celebrex (celecoxib) and removal of fluid for injection site joint inflammation, and he had to rent crutches for gait disturbance.Action taken: not applicable for all events.Outcome: recovered for injection site joint inflammation and it's symptoms and unknown for other events.A product technical complaint (ptc) was initiated on 16-may-2023 for synvisc one (unknown batch number) with global ptc number 100328431.Sample status was not available.Complaint: adverse event.Preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.(em 18may2023) investigation: the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to determine if a capa (corrective action and preventive action) is required.The final investigation was completed on 26-may-2023 with summarized conclusion as no assessment possible.Additional information was received on 26-may-2023 from other health care professional.Global ptc number, strength and result was added.Text amended accordingly.Additional information was received on 30-may-2023 from patient: patient medical history updated; concomitant added; drug start date added; event of injection site joint inflammation added; text amended.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 16973752
• MDR Text Key: 315678402
• Report Number: 2246315-2023-00054
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/05/2023; 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORTISONE (CORTISONE),UNKNOWN; DUROLANE (HYALURONIC ACID),UNKNOWN; DUROLANE (HYALURONIC ACID),UNKNOWN
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Sex: Male