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

Lot Number ARSL021

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Fluid that was pulled 3 times from 40-150ml [joint effusion], acute inflammation in the knee,inflammation is getting worse [joint inflammation] ([condition worsened]), fever gets worse [fever] ([condition aggravated]).Case narrative: initial information received on 11-oct-2021 from poland regarding an unsolicited valid serious case received from a patient mother.This case involves a (b)(6) female patient who experienced fluid that was pulled 3 times from 40-150ml, acute inflammation in the knee, inflammation is getting worse and fever gets worse with the use of medical device 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) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection dosage, frequency, route unknown (lot - unk).The information regarding lot number was requested.On an unknown date in 2021, after unknown latency, there was acute inflammation in the knee (arthritis), there was fluid that was pulled 3 times from 40-150ml (joint effusion; intervention required).Then arthroscopy was performed, until (b)(6) 2021, the inflammation was getting worse (condition aggravated).The inflammation lasted for the 6th month, the fever got worse (pyrexia and condition aggravated; start date: 2021 and latency unknown), the patient was afraid of sepsis.Relevant laboratory test results included: aspiration joint - in 2021: [40-150ml], arthroscopy: inflammation was worse.Corrective treatment: joint aspiration- fluid that was pulled 3 times from 40-150ml, not reported for rest of the events.At time of reporting, the outcome was not recovered / not resolved for all events.

Event Description

Fluid that was pulled 3 times from 40-150ml [joint effusion].Fever gets worse [fever] ([condition aggravated]).Acute inflammation in the knee,inflammation is getting worse [arthritis aggravated].Case narrative: initial information received on 11-oct-2021 from poland regarding an unsolicited valid serious case received from a patient's mother.This case involves a 38-year-old female patient who experienced fluid that was pulled 3 times from 40-150ml, acute inflammation in the knee, inflammation is getting worse and fever gets worse with the use of medical device 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) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 48 mg/ 6 ml) dosage, frequency, route unknown (lot - unk).The information regarding lot number was requested.On an unknown date in 2021, after unknown latency, there was acute inflammation in the knee (arthritis), there was fluid that was pulled 3 times from 40-150ml (joint effusion; intervention required).Then arthroscopy was performed, until (b)(6) 2021, the inflammation was getting worse.The inflammation lasted for the 6th month, the fever got worse (pyrexia and condition aggravated; start date: 2021 and latency unknown), the patient was afraid of sepsis.Relevant laboratory test results included: aspiration joint - in 2021: [40-150ml].Arthroscopy: inflammation was worse.Corrective treatment: joint aspiration- fluid that was pulled 3 times from 40-150ml, not reported for rest of the events.At time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated with global ptc number (b)(4) from synvisc one on 12-oct-2021 for product.Batch number; unknown.Sample status: not available.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa(corrective and preventive action) is required.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 ncr(nonconformance 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 has not indicated any safety issue.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to be determine if a capa is required.Final investigation complete date: 29-oct-2021 with summary code as no assessment possible.Follow up information was received on 11-oct-2021 from the other healthcare professional.Global ptc number added.No significant information was added.Additional information was received on 29-oct-2021 from the other healthcare professional.Ptc results added.Text amended accordingly.

Event Description

Fluid that was pulled 3 times from 40-150ml [joint effusion] fever gets worse [fever] ([condition aggravated]) acute inflammation in the knee,inflammation is getting worse [arthritis aggravated] case narrative: initial information received on (b)(6) 2021 from poland regarding an unsolicited valid serious case received from a patient mother.This case involves a 38-year-old female patient who experienced fluid that was pulled 3 times from 40-150ml, acute inflammation in the knee, inflammation is getting worse and fever gets worse with the use of medical device 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) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection dosage, frequency, route unknown (lot - unk).The information regarding lot number was requested.On an unknown date in 2021, after unknown latency, there was acute inflammation in the knee (arthritis), there was fluid that was pulled 3 times from 40-150ml (joint effusion; intervention required).Then arthroscopy was performed, until (b)(6) 2021, the inflammation was getting worse.The inflammation lasted for the 6th month, the fever got worse (pyrexia and condition aggravated; start date: 2021 and latency unknown), the patient was afraid of sepsis.Relevant laboratory test results included: aspiration joint - in 2021: [40-150ml] arthroscopy: inflammation was worse corrective treatment: joint aspiration- fluid that was pulled 3 times from 40-150ml, not reported for rest of the events at time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one (lot number unknown) with global ptc number (b)(4) and results were pending for the same.Follow up information was received on 11-oct-2021 from the other healthcare professional.Global ptc number added.No significant information was added.

Event Description

Fluid that was pulled 3 times from 40-150ml [joint effusion].Fever gets worse [fever] ([condition aggravated]).Acute inflammation in the knee,inflammation is getting worse [arthritis aggravated].Case narrative: initial information received on (b)(6) 2021 from poland regarding an unsolicited valid serious case received from a patient's mother.This case involves a 38-year-old female patient who experienced fluid that was pulled 3 times from 40-150ml, acute inflammation in the knee, inflammation is getting worse and fever gets worse with the use of medical device 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) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 48 mg/ 6 ml) dosage, frequency, route unknown (lot - arsl021; expiry date: 30-sep-2021).On an unknown date in 2021, after unknown latency, there was acute inflammation in the knee (arthritis), there was fluid that was pulled 3 times from 40-150ml (joint effusion; intervention required).Then arthroscopy was performed, until 11-oct-2021, the inflammation was getting worse.The inflammation lasted for the 6th month, the fever got worse (pyrexia and condition aggravated; start date: 2021 and latency unknown), the patient was afraid of sepsis.Reportedly, the doctors were looking for rheumatoid diseases, lyme disease and finally all these diseases were ruled out on the basis of detailed studies.The condition was getting more and more serious, demanding detailed bacteriological tests, in particular that, according to websites outside our country, there are some infected synvisc one drugs.Reportedly, the patient condition did not improve.Relevant laboratory test results included: aspiration joint - in 2021: [40-150ml] arthroscopy: inflammation was worse.Corrective treatment: joint aspiration- fluid that was pulled 3 times from 40-150ml, not reported for rest of the events.At time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated with global ptc number (b)(6) from synvisc one on (b)(6) 2021 for product.Batch number; unknown.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) is required.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 ncr(nonconformance 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 has not indicated any safety issue.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to be determine if a capa is required.Final investigation complete date: 29-oct-2021 with summary code as no assessment possible and investigation reopened after receipt of lot number.Follow up information was received on 11-oct-2021 from the other healthcare professional.Global ptc number added.No significant information was added.Additional information was received on 29-oct-2021 from the other healthcare professional.Ptc results added.Text amended accordingly.Additional information was received on 31-oct-2021, 27-oct-2021, 03-nov-2021 (processed with csd: (b)(6) 2021) from the patient mother and other healthcare professional.Lot number updated.Clinical course was updated.Text amended accordingly.

Event Description

Fluid that was pulled 3 times from 40-150ml [joint effusion].Fever gets worse [fever] ([condition aggravated]).Acute inflammation in the knee,inflammation is getting worse [arthritis aggravated].Case narrative: initial information received on 11-oct-2021 from poland regarding an unsolicited valid serious case received from a patient's mother.This case involves a 38-year-old female patient who experienced fluid that was pulled 3 times from 40-150ml, acute inflammation in the knee, inflammation is getting worse and fever gets worse with the use of medical device 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) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 48 mg/ 6 ml) dosage, frequency, route unknown (lot: arsl021; expiry date: 30-sep-2021).On an unknown date in 2021, after unknown latency, there was acute inflammation in the knee (arthritis), there was fluid that was pulled 3 times from 40-150ml (joint effusion; intervention required).Then arthroscopy was performed, until on (b)(6)2021, the inflammation was getting worse.The inflammation lasted for the 6th month, the fever got worse (pyrexia and condition aggravated; start date: 2021 and latency unknown), the patient was afraid of sepsis.Reportedly, the doctors were looking for rheumatoid diseases, lyme disease and finally all these diseases were ruled out on the basis of detailed studies.The condition was getting more and more serious, demanding detailed bacteriological tests, in particular that, according to websites outside our country, there are some infected synvisc one drugs.Reportedly, the patient condition did not improve.Relevant laboratory test results included: aspiration joint - in 2021: [40-150ml].Arthroscopy: inflammation was worse.Corrective treatment: joint aspiration- fluid that was pulled 3 times from 40-150ml, not reported for rest of the events.At time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated with global ptc number: (b)(4) on 12-oct-2021 for product.Batch number; arsl021.Sample status: not available.The production and quality control documentation for lot number: arsl021; expiration date (2023-09) 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: arsl021 no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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.As of 08-nov-2021, there were 2 complaints on file for lot number: arsl021 and all related sublots.2 complaints were on file for lot number: arsl021: (2) adverse event reports.Final investigation complete date was 10-nov-2021.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa was required.Follow up information was received on 11-oct-2021 from the other healthcare professional.Global ptc number added.No significant information was added.Additional information was received on 29-oct-2021 from the other healthcare professional.Ptc results added.Text amended accordingly.Additional information was received on 31-oct-2021, 27-oct-2021, 03-nov-2021 (processed with csd: 31-oct-2021) from the patient mother and other healthcare professional.Lot number updated.Clinical course was updated.Text amended accordingly.Additional information was received on 10-nov-2021 from the other healthcare professional.Updated ptc results added.Text 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: 12655008
• MDR Text Key: 283845212
• Report Number: 2246315-2021-00166
• 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,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/16/2021

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 Expiration Date: 09/30/2023
• Device Lot Number: ARSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2021; 11/07/2021; 11/09/2021; 11/16/2021
• 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
• Patient Sex: Female