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

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Extreme pain from synvisc injection [pain nos].Can not bend her leg due to stiffness [limbs stiffness] ([joint range of motion decreased]).She can barely walk at this point [walking difficulty].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference mw5097696.This case involves an unknown age female patient who experienced extreme pain from synvisc injection, can not bend her leg due to stiffness and she can barely walk at this point, while she was treated with 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 an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate (strength: 8mg/ml) via intra articular route (dose, frequency and batch number unknown) for unknown indication.On an unknown date, after unknown latency, patient was in extreme pain from hylan g-f 20, sodium hyaluronate injection (pain), could not bend her leg due to stiffness (musculoskeletal stiffness) (joint range of motion decreased) and she could barely walk at this point (gait disturbance).These events were assessed as medically significant.Therefore, it was advised to patient to take aleve or tylenol and to go to care or emergency room if necessary because this was an abnormal reaction to hylan g-f 20, sodium hyaluronate which was not common at all.Action taken: unknown for all events.The patient was treated with naproxen sodium (aleve) and paracetamol (tylenol) for all events.The patient outcome is reported as unknown for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 08-jan-2021 for product.Batch number; unknown.Device not returned.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) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance 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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation complete date: 21-jan-2021.Additional information was received on 21-jan-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.

Event Description

Extreme pain from synvisc injection [pain nos] can not bend her leg due to stiffness [limbs stiffness] ([joint range of motion decreased]) she can barely walk at this point [walking difficulty].Case narrative: this case is deleted following an incorrect worldwide id.The new case (b)(4) will be submitted with the same information.Initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference mw5097696.This case involves an unknown age female patient who experienced extreme pain from synvisc injection, can not bend her leg due to stiffness and she can barely walk at this point, while she was treated with 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 an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate (strength: 8mg/ml) via intra articular route (dose, frequency and batch number unknown) for unknown indication.On an unknown date, after unknown latency, patient was in extreme pain from hylan g-f 20, sodium hyaluronate injection (pain), could not bend her leg due to stiffness (musculoskeletal stiffness) (joint range of motion decreased) and she could barely walk at this point (gait disturbance).These events were assessed as medically significant.Therefore, it was advised to patient to take aleve or tylenol and to go to care or emergency room if necessary because this was an abnormal reaction to hylan g-f 20, sodium hyaluronate which was not common at all.Action taken: unknown for all events.The patient was treated with naproxen sodium (aleve) and paracetamol (tylenol) for all events.The patient outcome is reported as unknown for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 08-jan-2021 for product.Batch number; unknown.Device not returned.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) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance 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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation complete date: 21-jan-2021.Additional information was received on 21-jan-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11257049
• MDR Text Key: 229612134
• Report Number: 2246315-2021-00053
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention