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

Lot Number DRSL023A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Nausea (1970); Loss of Range of Motion (2032); Chills (2191); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 31-jan-2024: this case involves an unknown age female patient whose orthopedic surgeon quickly removed almost 2 full syringe of fluid and once the culture came back it showed a really bad allergy to synvisc while being treated with hylan g-f 20, sodium hyaluronate.This case currently lack sufficient and consistent information to permit a proper assessment.A better description including chronology, as well as information on family history if any and relevant medical history of the patient, as well as concurrent conditions are currently missing.The case will be reassessed based on follow-up information that will be received.

Event Description

Culture came back it showed a really bad allergy to synvisc [allergic reaction].([injection site joint effusion], [condition aggravated], [joint stiffness], [joint range of motion decreased], [injection site joint swelling], [unable to walk], [injection site joint pain], [chills], [nausea]).Removed almost 2 full syringe of fluid and once the culture came back it showed a really bad allergy to synvisc [arthrocentesis].Case narrative: initial information received from canada on 23-jan-2024 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age female patient whose orthopedic surgeon quickly removed almost 2 full syringe of fluid and once the culture came back it showed a really bad allergy to synvisc while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2023 at 09:30 , the patient started taking hylan g-f 20, sodium hyaluronate injection of strength 48mg/6ml once (with an unknown batch number, expiry date, route, indication, dose).Information on batch number and expiry date was requested.On (b)(6) 2023 at 18:00; latency: 8 hrs 30 min, patient had knee pain that was bad (injection site joint pain)but since had received this type of injection in the past she thought it was ok but she never felt bad pain like this.On 31-dec-2023, latency: 2 days, patient was in excruciating pain (condition aggravated) and was unable to walk (gait inability) or bend her knee(joint stiffness)(joint range of motion decreased).She started experiencing chills, nausea and her knee felt like it was going to explode(injection site joint swelling).Her knee had become so swollen that no amount medications took the pain away.She ended up at the emergency and her pain was so bad that dilaudid was not helping.On an unknown date in (b)(6) 2023, few days, they called the orthopedic surgeon on call and he quickly removed almost 2 full syringe of fluid(aspiration joint; seriousness criteria: medically significant)(injection site joint effusion) and once the culture came back it showed a really bad allergy to synvisc(hypersensitivity; seriousness criteria: medically significant, intervention).She was disappointed because she spend almost 500 dollar and it was the worst experience of her life.No additional information available action taken was not applicable for all events.The patient was treated with hydromorphone hydrochloride (dilaudid) for injection site joint pain(symptom of hypersensitivity); and not reported for rest events.At time of reporting, the outcome was unknown for all events.

Event Description

Culture came back it showed a really bad allergy to synvisc [allergic reaction] ([injection site joint effusion], [condition aggravated], [joint stiffness], [joint range of motion decreased], [injection site joint swelling], [unable to walk], [injection site joint pain], [chills], [nausea]) removed almost 2 full syringe of fluid and once the culture came back it showed a really bad allergy to synvisc [arthrocentesis].Case narrative: initial information received from canada on 23-jan-2024 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age female patient whose orthopedic surgeon quickly removed almost 2 full syringe of fluid and once the culture came back it showed a really bad allergy to synvisc while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2023 at 09:30 , the patient started taking hylan g-f 20, sodium hyaluronate injection of strength 48mg/6ml once (with an unknown route, indication, dose), batch number: drsl023a and expiration date: 31-mar-2026.On (b)(6) 2023 at 18:00; latency: 8 hrs 30 min, patient had knee pain that was bad (injection site joint pain)but since had received this type of injection in the past she thought it was ok but she never felt bad pain like this.On (b)(6) 2023 , latency: 2 days, patient was in excruciating pain (condition aggravated) and was unable to walk (gait inability) or bend her knee(joint stiffness)(joint range of motion decreased) and could not stand.She started experiencing chills, nausea and her knee felt like it was going to explode(injection site joint swelling).Her knee had become so swollen that no amount medications took the pain away.She ended up at the emergency and her pain was so bad that dilaudid was not helping.The patient could not walk on the leg.It was more than that.The patient had never felt such pain in her life and went to the emergency room.On an unknown date in (b)(6) 2023 few days, they called the orthopedic surgeon on call and he quickly removed almost 2 full syringe of fluid(aspiration joint; seriousness criteria: medically significant)(injection site joint effusion) and once the culture came back it showed a really bad allergy to synvisc(hypersensitivity; seriousness criteria: medically significant, intervention).She was disappointed because she spend almost 500 dollar and it was the worst experience of her life.The patient does not know why there was this allergic reaction and now the knee is killing her because of all the inflammation.The patient wanted a refund because it was a lot of money.No additional information available action taken was not applicable for all events.The patient was treated with hydromorphone hydrochloride (dilaudid) for injection site joint pain(symptom of hypersensitivity); and not reported for rest events.At time of reporting, the outcome was unknown for all events.A product technical complaint (ptc) was initiated on 23-jan-2024 for synvisc one.Batch number; unknown global ptc number: (b)(4).Sample status of ptc was not available, and ptc stated 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.(b)(6) 2024 investigation: (b)(6) 2024 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 actions) was required.The final investigation was completed on 06-feb-2024 with summarized conclusion as no assessment possible.Additional information was received from the patient on 26-jan-2024 from the patient.Batch number and expiration date was added.Narrative was updated.Text amended accordingly.Additional information was received on 06-feb-2024 by quality department form other health care professional: ptc complete details added; text amended.

Event Description

Unable to walk or bend my knee [joint range of motion decreased] could not stand [difficulty in standing] unable to walk or bend my knee/could not walk on the leg [unable to walk] culture came back it showed a really bad allergy to synvisc [allergic reaction] ([injection site joint effusion], [arthrocentesis], [injection site joint inflammation], [injection site joint swelling], [injection site joint pain], [nausea], [chills]) my knee pain was bad but since i had received this type of injection in the past i thought it was ok but i never felt bad pain like this.48hours later i was in excruciating pain [condition aggravated] case narrative: initial information was received from canada on (b)(6) 2024 regarding an unsolicited valid serious case from a patient.This case involves a 52 years old female patient who reported that she could not stand, unable to walk or bend my knee/could not walk on the leg and culture came back it showed a really bad allergy to synvisc while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2023 at 09:30, the patient started taking hylan g-f 20, sodium hyaluronate injection of strength 48mg/6ml once (with an unknown route, indication, dose; batch number: drsl023a and expiration date: 31-mar-2026).On (b)(6) 2023 at 18:00; latency: 8 hrs 30 min, patient had knee pain that was bad (injection site joint pain, required intervention and medically significant) but since had received this type of injection in the past she thought it was ok but she never felt bad pain like this.On (b)(6) 2023, latency: 2 days, patient was in excruciating pain (injection site joint pain, condition aggravated) and was unable to walk (gait inability, medically significant) or bend her knee (joint range of motion decreased, medically significant) and could not stand (dysstasia, medically significant).She started experiencing chills, nausea and her knee felt like it was going to explode (injection site joint swelling) (all required intervention and medically significant).Her knee had become so swollen that no amount medications took the pain away (injection site joint swelling).She ended up at the emergency and her pain was so bad that dilaudid was not helping (injection site joint pain).The patient could not walk on the leg (gait inability, medically significant).It was more than that.The patient had never felt such pain in her life and went to the emergency room.On an unknown date in (b)(6) 2023, few days, they called the orthopedic surgeon on call and he quickly removed almost 2 full syringe of fluid (injection site joint effusion, aspiration joint; intervention required and medically significant) and once the culture came back it showed a really bad allergy to synvisc (hypersensitivity; medically significant, required intervention).She was disappointed because she spent almost 500 dollar and it was the worst experience of her life.The patient did not know why there was this allergic reaction and now the knee was killing her because of all the inflammation (injection site joint inflammation, onset date: on (b)(6) 2023, latency: few days, required intervention and medically significant).The patient wanted a refund because it was a lot of money.No additional information available.Action taken was not applicable for all events.Corrective treatment: hydromorphone hydrochloride (dilaudid) and removed almost 2 full syringe of fluid for hypersensitivity; not reported for rest of the events.At time of reporting, the outcome was unknown for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2024 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: drsl023a and expiry date: 31-mar-2026) with global ptc number: (b)(4).Sample status of ptc was not available, and ptc stated 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.(rc on (b)(6)2024) batch number drsl023a, synvisc was manufactured on 19apr2023 with expiration date of 31mar2026 yielding (b)(4) singles.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.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.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Trend analysis: there are three (3) complaints for mother lot drsl023a and sub-batches.100380916 drsl023a device is jammed/blocked100380916 drsl023a syringe broken while use100395371 drsl023a allergic reaction/other pharmacovigilance event based on investigation and trend analysis, no capa required.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis to determine if a capa is required.This review has not indicated any safety issue.The final investigation was completed on 13-feb-2024 with summarized conclusion as no assessment possible.Additional information was received from the patient on 26-jan-2024 from the patient.Batch number and expiration date was added.Narrative was updated.Text amended accordingly.Additional information was received on 06-feb-2024 by quality department form other health care professional: ptc complete details added; text amended.Additional information was received on 06-feb-2024 from quality department: batch number and expiry date updated.Text was amended accordingly.Additional information was received on 13-feb-2024 from quality department: ptc results were updated.Also, upon internal review, event was added- could not stand.Symptom- unable to walk or bend my knee/could not walk on the leg was updated to main diagnosis.Text was amended accordingly.

Event Description

Culture came back it showed a really bad allergy to synvisc [allergic reaction] ([injection site joint effusion], [condition aggravated], [joint stiffness], [joint range of motion decreased], [injection site joint swelling], [unable to walk], [injection site joint pain], [chills], [nausea]).Removed almost 2 full syringe of fluid and once the culture came back it showed a really bad allergy to synvisc [arthrocentesis].Case narrative: initial information received from canada on 23-jan-2024 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age female patient whose orthopedic surgeon quickly removed almost 2 full syringe of fluid and once the culture came back it showed a really bad allergy to synvisc while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2023 at 09:30, the patient started taking hylan g-f 20, sodium hyaluronate injection of strength 48mg/6ml once (with an unknown route, indication, dose; batch number: drsl023a and expiration date: 31-mar-2026).On (b)(6) 2023 at 18:00; latency: 8 hrs 30 min, patient had knee pain that was bad (injection site joint pain)but since had received this type of injection in the past she thought it was ok but she never felt bad pain like this.On (b)(6) 2023, latency: 2 days, patient was in excruciating pain (condition aggravated) and was unable to walk (gait inability) or bend her knee (joint stiffness) (joint range of motion decreased) and could not stand.She started experiencing chills, nausea and her knee felt like it was going to explode (injection site joint swelling).Her knee had become so swollen that no amount medications took the pain away.She ended up at the emergency and her pain was so bad that dilaudid was not helping.The patient could not walk on the leg.It was more than that.The patient had never felt such pain in her life and went to the emergency room.On an unknown date on (b)(6) 2023, few days, they called the orthopedic surgeon on call and he quickly removed almost 2 full syringe of fluid (aspiration joint; seriousness criteria: medically significant) (injection site joint effusion) and once the culture came back it showed a really bad allergy to synvisc (hypersensitivity; seriousness criteria: medically significant, intervention).She was disappointed because she spend almost 500 dollar and it was the worst experience of her life.The patient does not know why there was this allergic reaction and now the knee is killing her because of all the inflammation.The patient wanted a refund because it was a lot of money.No additional information available.Action taken was not applicable for all events.The patient was treated with hydromorphone hydrochloride (dilaudid) for injection site joint pain(symptom of hypersensitivity); and not reported for rest events.At time of reporting, the outcome was unknown for all events.A product technical complaint (ptc) was initiated on 23-jan-2024 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: drsl023a and expiry date: 31-mar-2026) with global ptc number: (b)(4).Sample status of ptc was not available, and ptc stated 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.(rc 25jan2024) investigation: (rc 06feb2024) 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 actions) was required.The final investigation was completed on 06-feb-2024 with summarized conclusion as no assessment possible.Additional information was received from the patient on (b)(6) 2024 from the patient.Batch number and expiration date was added.Narrative was updated.Text amended accordingly.Additional information was received on 06-feb-2024 by quality department form other health care professional: ptc complete details added; text amended.Additional information was received on 06-feb-2024 from quality department: batch number and expiry date updated.Text was amended accordingly.

• 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: 18614777
• MDR Text Key: 334259940
• Report Number: 2246315-2024-00005
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: DRSL023A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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
• Patient Sex: Female