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

Lot Number BRSL039

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

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

Event Date 05/31/2022

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2022: this case involves an unknown age male patient who had knee surgery with the use of medical device hylan g-f 20, sodium hyaluronate synvisc.Based on the available information, causal relationship between the events and suspect product could not be denied.However; further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Knee surgery knee surgery nos until the present moment, my pain and relief continue with the same intensity postoperative pain.Lack of efficacy/ the result and the expectation of pain reduction and relief device ineffective.Case narrative: initial information received on (b)(6) 2022 from brazil regarding an unsolicited valid serious case received from the patient.This case involves an unknown age male patient who had knee surgery and until the present moment, my pain and relief continue with the same intensity 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.On (b)(6) 2022, the patient received synvisc injection dosage unknown (lot, expiry date, dose, route, frequency, strength - unknown) for product used for unknown indication.Purchased this medication and received it on (b)(6) 2022.In which through a professional in clinic, by a doctor in knee surgery(knee operation).It was carried out on (b)(6) 2022 (latency: same day, medically significant).Over the months in 2022 , the result and the expectation of pain reduction and relief(device ineffective) , until the present moment, my pain and relief continue with the same intensity(procedural pain).Action taken: unknown.An unknown corrective treatment was received for the event (knee surgery).It was not reported if the patient received a corrective treatment for the events (until the present moment, my pain and relief continue with the same intensity, lack of efficacy/ the result and the expectation of pain reduction and relief).At time of reporting, the outcome was not recovered/not resolved for the event until the present moment, my pain and relief continue with the same intensity and was unknown for the event knee surgery.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Lack of efficacy/ the result and the expectation of pain reduction and relief with no adverse event [device ineffective].Case narrative: initial information received on 07-oct-2022 from (b)(6) regarding an unsolicited valid non-serious case received from the patient.This case involves an unknown age male patient who experienced lack of efficacy/ the result and the expectation of pain reduction and relief with no adverse event 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) 2022, the patient received synvisc one injection (lot: brsl039 and expiry date: 30-sep-2024 having the strength 48mg/6ml (dose, route, frequency: unknown) for reduction of pain and relief (knee pain).On an unknown date the patient developed an event of a non-serious "lack of efficacy/ the result and the expectation of pain reduction and relief with no adverse event" (device ineffective) (unknown latency) after starting use of hylan g-f 20 and sodium hyaluronate.It was reported, " i come to this space to inform you that i purchased this medication and received it on (b)(6) 2022.In which through a professional in clinic, by a doctor in knee surgery.It was carried out on (b)(6) 2022.Over the months, the result and the expectation of pain reduction and relief, until the present moment, my pain and relief continue with the same intensity." action taken: not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was unknown for device ineffective.A product technical complaint (ptc) was initiated on 07-oct-2022 for synvisc one (lot/batch number: brsl039 and expiry date: 30-sep-2024) with global ptc number: (b)(4).The sample status of the ptc was not received and the ptc stated:the production and quality control documentation for lot # brsl039 expiration date (2024-09) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # brsl039 no capa (corrective and preventive action) was 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 19-oct-2022 there are 14 complaints on file for lot#brsl039 and all related sub-lots.2 complaints are on file for lot# brsl039: (2) adverse event reports.There are 11 complaints on file for lot# brsl039c: (10) adverse event reports and (1) extrusion issue.1 complaint is on file for lot# brsl039d: (1) syringe tip broken.Sanofi will continue to monitor complaints to determine if a capa was required.The final investigation was completed on 14-nov-2022 with summarized conclusion as no assessment possible.Additional information was received on 11-oct-2022 from the patient via call center.Batch number and indication was added.Text amended accordingly.Additional information was received on 14-nov-2022 from the quality department.Ptc details and strength was added.Based on information previously received, the following information have been amended: the case was updated to a non-serious case.The events of knee operation and procedural pain were deleted.Text amended accordingly.Local comments: *downgrade*.

Manufacturer Narrative

Sanofi company comment dated 16-oct-2022: this case involves an unknown age male patient who had knee surgery with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Knee surgery [knee surgery nos] until the present moment, my pain and relief continue with the same intensity [postoperative pain] lack of efficacy/ the result and the expectation of pain reduction and relief [device ineffective] case narrative: initial information received on 07-oct-2022 from brazil regarding an unsolicited valid serious case received from the patient.This case involves an unknown age male patient who had knee surgery and until the present moment, my pain and relief continue with the same intensity 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.On (b)(6) 2022, the patient received synvisc injection dosage unknown (lot: brsl039 and expiry date, dose, route, frequency, strength - unknown) for reduction of pain and relief (knee pain).Purchased this medication and received it on (b)(6) 2022.In which through a professional in clinic, by a doctor in knee surgery(knee operation).It was carried out on (b)(6) 2022 (latency: same day, medically significant).Over the months in 2022 , the result and the expectation of pain reduction and relief(device ineffective) , until the present moment, my pain and relief continue with the same intensity(procedural pain).Action taken: unknown an unknown corrective treatment was received for the event (knee surgery).It was not reported if the patient received a corrective treatment for the events (until the present moment, my pain and relief continue with the same intensity, lack of efficacy/ the result and the expectation of pain reduction and relief).At time of reporting, the outcome was not recovered/not resolved for the event until the present moment, my pain and relief continue with the same intensity and was unknown for the event knee surgery.A product technical complaint (ptc) was initiated, and the results were pending for the same.Additional information was received on 11-oct-2022 from the patient via call center.Batch number and indication was added.Text amended accordingly.

Event Description

Knee surgery [knee surgery nos] until the present moment, my pain and relief continue with the same intensity [postoperative pain] ([device ineffective]).Case narrative: initial information received on 07-oct-2022 from brazil regarding an unsolicited valid serious case received from the patient.This case involves an unknown age male patient who had knee surgery and until the present moment, my pain and relief continue with the same intensity 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) 2022, the patient received synvisc one injection (lot: brsl039 and expiry date: 30-sep-2024 having the strength 48mg/6ml (dose, route, frequency: unknown) for reduction of pain and relief (knee pain).Purchased this medication and received it on 26-may-2022.In which through a professional in clinic, by a doctor in knee surgery(knee operation).It was carried out on (b)(6) 2022 (latency: same day, medically significant).Over the months in 2022 , the result and the expectation of pain reduction and relief (device ineffective) , until the present moment, my pain and relief continue with the same intensity(procedural pain).Action taken: not applicable.An unknown corrective treatment was received for the event (knee surgery).It was not reported if the patient received a corrective treatment for the events (until the present moment, my pain and relief continue with the same intensity, lack of efficacy/ the result and the expectation of pain reduction and relief).At time of reporting, the outcome was not recovered/not resolved for the event until the present moment, my pain and relief continue with the same intensity and was unknown for the event knee surgery.A product technical complaint (ptc) was initiated on 07-oct-2022 for synvisc one (lot/batch number: brsl039 and expiry date: 30-sep-2024) with global ptc number: (b)(4).The sample status of the ptc was not received and the ptc stated:the production and quality control documentation for lot # brsl039 expiration date (2024-09) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # brsl039 no capa (corrective and preventive action) was 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 19-oct-2022 there are 14 complaints on file for lot#brsl039 and all related sub-lots.2 complaints are on file for lot# brsl039: (2) adverse event reports.There are 11 complaints on file for lot# brsl039c: (10) adverse event reports and (1) extrusion issue.1 complaint is on file for lot# brsl039d: (1) syringe tip broken.Sanofi will continue to monitor complaints to determine if a capa was required.The final investigation was completed on 14-nov-2022 with summarized conclusion as no assessment possible.Additional information was received on 11-oct-2022 from the patient via call center.Batch number and indication was added.Text amended accordingly.Additional information was received on 14-nov-2022 from the quality department.Ptc details and strength was added.

• 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: 15619133
• MDR Text Key: 301901539
• Report Number: 2246315-2022-00128
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: BRSL039
• 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): Other; Required Intervention
• Patient Sex: Male