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

Lot Number UNKNOWN

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

Patient Problems Cardiovascular Insufficiency (4445); Hormonal Imbalance (4495); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Hypothyroid [hypothyroidism] , poor circulation [circulatory insufficiency], it's hard to walk and ride her bike [walking difficulty].Case narrative: this case was cross referenced to (b)(4) (multiple device, left knee).Initial information received on 06-jul-2021 from united states regarding an unsolicited valid serious case received from a patient.This case involves a (b)(6) years old female patient who experienced hypothyroid, poor circulation and it's hard to walk and ride her bike with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In 2016, the patient started using hylan g-f 20, sodium hyaluronate injection, 8 mg/ml, dosage 2.25 ml, weekly thrice (2.25 ml x3) unknown (lot - unk) for m17.0 for bilateral primary osteoarthritis of knee.The information regarding lot number was requested.The patient received the first and last injection of synvisc on both knees and had not had anything else since then.The patient was applying to get another injection of the hylan g-f 20, sodium hyaluronate for both knees.On an unknown date, after unknown latency, the patient was diagnosed with hypothyroid (hypothyroidism; medically significant) and poor circulation (cardiovascular insufficiency; medically significant) and it was hard to walk and ride her bike (gait disturbance).Action taken- unknown for the events.The corrective treatment was unknown for the events.At time of reporting, the outcome was not recovered for the all the events.

Event Description

Hypothyroid [hypothyroidism] poor circulation [circulatory insufficiency] its hard to ride her bike [driving ability disturbed] it's hard to walk [walking difficulty] got all 3 injections at the same time on her right knee with no reported adverse event [off label use of device] case narrative: initial information received on 06-jul-2021 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of patient support program "psp_saus.Tjo.012".This case is cross referred to the cases (b)(4) (left knee), (b)(4) (left knee), 2021sa231049 (right knee), (b)(4) (right knee), (b)(4) (left knee) (multiple device suspect used for the same patient); (b)(4) (left knee; duplicate) and (b)(4) (right knee; duplicate).Patient id: (b)(6); country: united states.Study title: sanofi patient connection.This case involves a 67 years old female patient who got all 3 injections at the same time on her right knee with no reported adverse event and experienced hypothyroid, poor circulation and it's hard to walk and ride her bike after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In 2016, the patient started using hylan g-f 20, sodium hyaluronate injection (8 mg/ml), at dose of 3 injections of 2.25 ml each at the same time on her right knee (3rd injection) (with an unknown strength, route, batch number and expiry date) for bone on bone with arthritis/bilateral primary osteoarthritis of knee (off label use of device; latency: same day).The information regarding lot number was requested.First time product used : no.The patient received the first and last injection of synvisc on both knees and had not had anything else since then.The consumer mentioned that she got all 3 injections at the same time on her left knee, and all 3 injection on her right knee at the same time (however were intended to be taken as 1 injection weekly).The consumer told the orthopedic doctor that she doesn't want to waste his time nor she wants him to waste her time.The consumer mentioned that it worked for her and it is the only one that works for her, and she could be a spokesperson for this injection.On an unknown date, after unknown latency, the patient was diagnosed with hypothyroid (hypothyroidism; medically significant) and poor circulation (cardiovascular insufficiency; medically significant) and it was hard to walk and ride her bike (gait disturbance) and (impaired driving ability; seriousness criteria: disability).It was also reported that the patient was applying to get another injection of the hylan g-f 20, sodium hyaluronate for both knees.At the time of the report, the synvisc is continued.The consumer mentioned that it took 5 years for it to wear down, and now it's worn down and she knows she needs it again.The consumer called in saying that she was looking to see if someone can help them with the serum.The consumer said that a representative from the company gave her the number and other resources to help her with her medication, to help maybe with the payments.The consumer said that she would not take anything else because she had tried other products and that doesn't work, and this was the only thing that works, and if that means that this would help her, why would she take something else? the consumer said she wanted this injection, but she could not understand how some people could get help when their income was limited, and their income was limited and they had a house payment, and she thought that there was something out there that the company could do.The consumer said that she used synvisc for bone on bone, but she's sure that with age, she had arthritis.No additional information available.It was unknown if the patient experienced any additional symptoms/events.Action taken: not applicable for all the events.Corrective treatment: not reported for all the events.Outcome: unknown for off label use of device; not recovered for rest all the events.Reporter causality: not reported for all the events.Company causality: not reportable for all the events.A product technical complaint (ptc) was initiated on 06-jul-2021 for hylan g-f 20, sodium hyaluronate.Batch number: unknown; comet compliant id number: (b)(4).Sample status: not available.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.An attempt was made to confirm the product name as it was more probable that the product in question was synvisc rather than synvisc one simply due to its volume.Unfortunately, intake was unable to confirm this with the complainant.This and the other cases will be processed as they are.This investigation would be revised once more information becomes available.Sanofi would continue to monitor adverse events to determine if a capa was required final investigation complete date: 29-sep-2021 with summary code as no assessment possible.Additional information was received on 27-jul-2022 from consumer.No new significant information was received.Upon internal review the case (b)(4) (be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case (b)(4).The case (b)(4) received with clock start date of 06-jul-2021 will be deleted.Based on the information received the case was initially assessed as unsolicited was upgraded to solicited other.Additional case ids added.Additional event off label use of device was added with details.Ptc results added.Clinical course was updated and text amended accordingly.

• Brand Name: SYNVISC
• 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: 12169606
• MDR Text Key: 270179958
• Report Number: 2246315-2021-00123
• 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: Study,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2023
• 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
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Sex: Female