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 Problem Syncope/Fainting (4411)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Fainted between the injections [faint] : the left knee went 5, trying and guess what, the knee exploded swelling out of shape [injection site joint swelling].Was really sore for a long time (left knee) [injection site joint pain].Case narrative: initial information was received from finland on (b)(6) 2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to cases (b)(6) (multiple devices used in a single patient).This case involves a 57 years old adult and unknown gender patient who had a bad spiker, the left knee went 5, trying, guess what, the knee exploded swelling out of shape, was really sore for a long time and fainted between the injections with the use of a 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.It is unknown if the patient had any risk factor.At the time of the event, the patient had ongoing arthralgia.On an unknown date (in 2022), the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) (strength:48 mg/6 ml) injection at the left knee at an unknown dosage, frequency, route, expiry date, and batch number for osteoarthritis of the knees, with pricking.Information on batch number was requested.Patient reported that "this is the synvisc one preparation, which was injected into my arthritic knees for the fourth time now.During the first two times [injections], the response was good and occurred almost immediately.My knees became approximately 10-20 years "younger" and i don't need painkillers.Last year, a bad spiker, e.G.The left knee went 5.Trying and guess what, the knee "exploded" swelling out of shape and was really sore for a long time (injection site joint swelling) (injection site joint pain) (onset: 2022; unknown latency).No inflammation.My interest was that after several years of assistance with the product and now with such extensive adverse effects, i would have been interested to know if allergy could be excluded in order to make it possible to use the product.Now it has been announced that i can no longer be injected with synvisc one, while no other data is available.In 2022, the injection was not successful, and therefore patient assume that the adverse effect was caused by poor injecting rather than by synvisc one.The customer had mixed the years, so the injection she received in 2022 in the right knee was successful with second attempt, and the left knee was successful with the fifth attempt.The person, who injected was bad and inexperienced.The customer [patient] fainted between the injections (syncope) (syncope) (onset: 2022 and latency: unknown)." it is unknown if there were lab data/results available.Action taken: not applicable for all the events.Corrective treatment: not reported for the events.Outcome: unknown for syncope and not recovered / not resolved for all the other events.Seriousness criteria: medically significant for syncope.A ptc (product technical complaint) was initiated on (b)(6) 2023, for synvisc-one (batch number and expiry date: unknown) with global ptc number 100314093.The sample was not available.The ptc stated that based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.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 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 monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on (b)(6) 2023 with summarized conclusion as no assessment possible.Additional information was received on (b)(6) 2023 (taken as (b)(6) 2023 in general tab to avoid e2b error) via quality department.Ptc details and strength added; clinical course updated; text amended.Additional information was received on (b)(6) 2023 via consumer.Therapy start date added.Text amended.Additional information was received on (b)(6) 2023 via quality department.Ptc result details added; clinical course updated; text amended.Additional information was received on (b)(6) 2023 via patient.Based on this information, the case initially considered as non-serious was upgraded to serious; event syncope added; text amended.Based on the information previously received, the following information was amended: value for type of reportable event was added.

Event Description

Fainted between the injections [faint].The left knee went 5/the knee exploded swelling out of shape [injection site joint swelling].Was really sore for a long time (left knee) [injection site joint pain].Case narrative: initial information was received from finland on 10-mar-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to cases (b)(4) (multiple devices used in a single patient).This case involves a 57 years old adult female patient who had a bad spiker, the left knee went 5/the knee exploded swelling out of shape, was really sore for a long time and fainted between the injections with the use of a 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.It is unknown if the patient had any risk factor.At the time of the event, the patient had ongoing arthralgia.On an unknown date (in 2022), the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) (strength:48 mg/6 ml) injection at the left knee at an unknown dosage, frequency, route, expiry date, and batch number for osteoarthritis of the knees, with pricking.Information on batch number was requested.Patient reported that the synvisc one preparation, was injected into the arthritic knees for the fourth time now.During the first two times [injections], the response was good and occurred almost immediately.Patient's knees became approximately 10-20 years "younger" and did not need painkillers.The person, who injected in 2022 was bad and inexperienced.The customer [patient] fainted between the injections (syncope) (onset: 2022 and latency: same day).The injection in 2022 was a bad spiker, e.G.The left knee went 5.The knee "exploded" swelling out of shape and was really sore for a long time (injection site joint swelling) (injection site joint pain) (onset: 2022; unknown latency).No inflammation.Patient's interest was that after several years of assistance with the product and now with such extensive adverse effects, patient would have been interested to know if allergy could be excluded in order to make it possible to use the product.Now it has been announced that patient could no longer be injected with synvisc one, while no other data was available.In 2022, the injection was not successful, and therefore patient assumed that the adverse effect was caused by poor injecting rather than by synvisc one.The customer had mixed the years, so the injection patient received in 2022 in the right knee was successful with second attempt, and the left knee was successful with the fifth attempt.It is unknown if there were lab data/results available.Action taken: not applicable for all the events.Corrective treatment: not reported for the events.Outcome: unknown for syncope and not recovered / not resolved for all the other events.Seriousness criteria: medically significant for syncope.A ptc (product technical complaint) was initiated on 09-mar-2023, for synvisc-one (batch number and expiry date: unknown) with global ptc number 100314093.The sample was not available.The ptc stated that based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.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 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 monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 25-apr-2023 with summarized conclusion as no assessment possible.Additional information was received on 09-mar-2023 (taken as 10-mar-2023 in general tab to avoid e2b error) via quality department.Ptc details and strength added; clinical course updated; text amended.Additional information was received on 26-mar-2023 via consumer.Therapy start date added.Text amended.Additional information was received on 25-apr-2023 via quality department.Ptc result details added; clinical course updated; text amended.Additional information was received on 03-may-2023 via patient.Based on this information, the case initially considered as non-serious was upgraded to serious; event syncope added; text amended.Based on the information previously received, the following information was amended: value for type of reportable event was added.Based on information previously received, product tab was amended for following fields: expected side-effects updated to blank; does the incident represent a serious public threat: updated to no; unanticipated serious deterioration in health radio button should be ticked; was the device labeled sterile: marked yes; trained user: marked as unknown.

• 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: 16951534
• MDR Text Key: 315443371
• Report Number: 2246315-2023-00049
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

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 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: 05/18/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2023
• 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): Other; Required Intervention
• Patient Sex: Female