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

Lot Number 8RSL030B

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

Patient Problems Cyst(s) (1800); Inflammation (1932); Burning Sensation (2146); No Code Available (3191)

Event Date 11/20/2018

Event Type  Injury  

Event Description

Popliteal cyst [popliteal cyst].Could not walk [unable to walk].Inflammatory reaction/voluminous inflammation [joint inflammation] ([injection site joint pain], [injection site joint warmth], [effusion (r) knee]).Allergic reaction [allergic reaction].Case narrative: based on additional information received on 11-mar-2019, this case initially assessed as non-serious was upgraded to serious (seriousness criteria of intervention required, medically significant and disability was added).Additionally the case became medically confirmed.This case was cross referenced with case (b)(4) (multiple devices: left knee) and (b)(4) (duplicate).Initial information received from (b)(6) on 28-feb-2019 regarding an unsolicited valid serious case received from a consumer.This case involves a (b)(6) years old male patient who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and experienced an inflammatory reaction/voluminous inflammation (latency: 0 day), popliteal cyst, allergic reaction (latency: 2 months 2 days) and could not walk.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had gonarthrosis and a work stoppage since (b)(6) 2018.Also, patient had no notion of tobacco or alcohol consumption, diabetes type 2 and obesity.On (b)(6) 2018, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 48mg/6 ml, once (lot - 8rsl030b, 31-mar-2021) gonarthrosis in right knee.On the same day, in the evening, patient felt burning sensation in the knee, which was warm, had inflammatory reaction and could not walk (latency: 0 day).On (b)(6) 2018, patient had a puncture of joint fluid (latency: 2 days).On (b)(6) 2019, patient experienced an allergic reaction (latency: 2 months 2 days) after receiving the hylan g-f 20, sodium hyaluronate injection.On the same day, the patient had voluminous inflammation with popliteal cyst on right knee.The patient was recovering slowly after corticosteroids infiltration.The patient remained off work for medical reason.Corrective treatment: corticosteroids infiltration for inflammatory reaction/voluminous inflammation; not reported for rest.Outcome: not recovered for could not walk; recovering for rest of the events.A product technical complaint (ptc) was initiated on 12-mar-2019 for synvisc one.Batch number: 8rsl030b; global ptc number: (b)(4).The production and quality control documentation for lot number 8rsl030b expiration date (03/2021) was reviewed.The investigation showed that the product met specifications.No associated non- conformances were noted.Based on the lot number, batch record review & lot number frequency analysis for lot number 8rsl030b no capa is required.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 has not indicated any safety issue.As of 12-mar-2019 there are 4 complaints on file for lot number 8rsl030 and all related sublots.2 complaints are on file for lot number 8rsl030: (2) broken syringe barrels.2 complaints are on file for lot number 8rsl030b: (2) adverse event reports.Sanofi will continue to monitor complaints as stated in sop (b)(4) "product complaint handling" to determine if a capa was required.Seriousness criteria: disability, medically significant for all events and intervention required for inflammatory reaction/voluminous inflammation.Additional information was received on 11-mar-2019 and 12-mar-2019 (processed with clock start date of 11-mar-2019) from rheumatologist and the case became medically confirmed.Medical history was added.Indication for suspect was added.Verbatim of inflammatory reaction was updated to inflammatory reaction/voluminous inflammation.Events of popliteal cyst and allergic reaction were added with details.Seriousness criteria was added.Clinical course updated.Related case id added.Global ptc number and its results were added.Text amended accordingly.

Event Description

Popliteal cyst [popliteal cyst].Could not walk [unable to walk].Inflammatory reaction/voluminous inflammation [joint inflammation] ([injection site joint pain], [injection site joint warmth], [effusion (r) knee]).Case narrative: based on additional information received on 11-mar-2019, this case initially assessed as non-serious was upgraded to serious (seriousness criteria of intervention required, medically significant and disability was added).Additionally, the case became medically confirmed.This case was cross referenced with case (b)(4).Initial information received from france on 28-feb-2019 regarding an unsolicited valid serious case received from a patient.This case involves a 54 years old male patient who received treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and had a reaction on right knee due to which she experienced an inflammatory reaction/voluminous inflammation (latency: 0 day), popliteal cyst (latency: 0 day) and could not walk (latency: 0 day).This case concerns reaction on right knee.The patient's past medical history was diabetes type 2 and obesity.Also, patient had no notion of tobacco or alcohol consumption.At the time of the event, the patient had gonarthrosis and a work stoppage since oct-2018.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 48mg/6 ml, once (lot - 8rsl030b, (b)(6) 2021 for gonarthrosis in right knee.On the same day, in the evening, patient felt burning sensation in the knee, which was warm, had inflammatory reaction and could not walk (latency: 0 day).On the same day, the patient had voluminous inflammation with popliteal cyst (latency: 0 day) on right knee.On (b)(6) 2018, after 2 days, patient had a puncture of joint fluid which was sterile, orange and showed inflammatory fluid (cloudy fluid with 65% of lymphocytes, 19% of neutrophils and 16% of monocytes and histiocytes).The patient was recovering slowly after corticosteroids infiltration.The patient remained at least 3 months off work for medical reason.Corrective treatment: corticosteroids infiltration for inflammatory reaction/voluminous inflammation; joint puncture for all events.Outcome: recovering for all events.A product technical complaint (ptc) was initiated on (b)(6) 2019, for synvisc one.Batch number: 8rsl030b; global ptc number: (b)(4).The production and quality control documentation for lot number 8rsl030b expiration date (03/2021) was reviewed.The investigation showed that the product met specifications.No associated non- conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number 8rsl030b no capa is required.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 did not indicate any safety issue.As of 12-mar-19 there were 4 complaints on file for lot number 8rsl030 and all related sublots.2 complaints were on file for lot number 8rsl030: (2) broken syringe barrels.2 complaints were on file for lot number 8rsl030b: (2) adverse event reports.Sanofi would continue to monitor complaints to determine if a capa was required.Seriousness criteria: disability, medically significant for all events and intervention required for inflammatory reaction/voluminous inflammation.Additional information was received on 11-mar-2019 and 12-mar-2019 (processed with clock start date of (b)(6) 2019 from rheumatologist and the case became medically confirmed.Medical history was added.Indication for suspect was added.Verbatim of inflammatory reaction was updated to inflammatory reaction/voluminous inflammation.Events of popliteal cyst and allergic reaction were added with details.Seriousness criteria was added.Clinical course updated.Related case id added.Global ptc number and its results were added.Text amended accordingly.Upon internal review on (b)(6) 2019, with clock start date of (b)(6) 2019.Analysis of similar incidents added.Additional information received on 03-may-2019 from healthcare professional.Event of allergic reaction deleted.Event onset date updated for popliteal cyst.Outcome updated for could not walk.Corrective treatment details added.Clinical course updated.Text amended accordingly.Upon internal review on (b)(6) 2019 with clock start date (b)(6) 2019 narrative of the case was updated and analysis of similar incidents was incorporated in the case.

Event Description

Popliteal cyst [popliteal cyst] could not walk [unable to walk] inflammatory reaction/voluminous inflammation [joint inflammation] ([injection site joint pain], [injection site joint warmth], [effusion (r) knee]) allergic reaction [allergic reaction] case narrative: based on additional information received on 11-mar-2019, this case initially assessed as non-serious was upgraded to serious (seriousness criteria of intervention required, medically significant and disability was added).Additionally the case became medically confirmed.This case was cross referenced with case (b)(4).Initial information received from france on 28-feb-2019 regarding an unsolicited valid serious case received from a consumer.This case involves a 54 years old male patient who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and experienced an inflammatory reaction/voluminous inflammation (latency: 0 day), popliteal cyst, allergic reaction (latency: 2 months 2 days) and could not walk.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had gonarthrosis and a work stoppage since oct-2018.Also, patient had no notion of tobacco or alcohol consumption, diabetes type 2 and obesity.On (b)(6) 2018, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 48mg/6 ml, once (lot - 8rsl030b, (b)(6) 2021) gonarthrosis in right knee.On the same day, in the evening, patient felt burning sensation in the knee, which was warm, had inflammatory reaction and could not walk (latency: 0 day).On (b)(6) 2018, patient had a puncture of joint fluid (latency: 2 days).On(b)(6) 2019, patient experienced an allergic reaction (latency: 2 months 2 days) after receiving the hylan g-f 20, sodium hyaluronate injection.On the same day, the patient had voluminous inflammation with popliteal cyst on right knee.The patient was recovering slowly after corticosteroids infiltration.The patient remained off work for medical reason.Corrective treatment: corticosteroids infiltration for inflammatory reaction/voluminous inflammation; not reported for rest.Outcome: not recovered for could not walk; recovering for rest of the events.A product technical complaint (ptc) was initiated on (b)(6) 2019 for synvisc one.Batch number: 8rsl030b; global ptc number: (b)(4).The production and quality control documentation for lot number 8rsl030b expiration date (03/2021) was reviewed.The investigation showed that the product met specifications.No associated non- conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number 8rsl030b no capa is required.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 has not indicated any safety issue.As of (b)(6) 2019 there are 4 complaints on file for lot number 8rsl030 and all related sublots.2 complaints are on file for lot number 8rsl030: (2) broken syringe barrels.2 complaints are on file for lot number 8rsl030b: (2) adverse event reports.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product complaint handling" to determine if a capa was required.Seriousness criteria: disability, medically significant for all events and intervention required for inflammatory reaction/voluminous inflammation.Additional information was received on 11-mar-2019 and 12-mar-2019 (processed with clock start date of 11-mar-2019) from rheumatologist and the case became medically confirmed.Medical history was added.Indication for suspect was added.Verbatim of inflammatory reaction was updated to inflammatory reaction/voluminous inflammation.Events of popliteal cyst and allergic reaction were added with details.Seriousness criteria was added.Clinical course updated.Related case id added.Global ptc number and its results were added.Text amended accordingly.Upon internal review on (b)(6) 2019 with clock start date of (b)(6) 2019.Analysis of similar incidents added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 8435328
• MDR Text Key: 139291709
• Report Number: 2246315-2019-00087
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Lot Number: 8RSL030B
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 150