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

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 01/01/2021

Event Type  Injury  

Event Description

Having fluid in the soft tissue of the right- knee [effusion (r) knee].Having fluid in the soft tissue of the right- knee [arthrocentesis].Not being able to bear weight on the right leg [weight bearing difficulty].Can't put her feet down, it's swollen and constant pain [pain in foot].Can't put her feet down it's swollen and constant pain [swelling of feet].Not being able to walk [unable to walk].Pain in the knee (right knee) [aching (r) knee].Case narrative: initial information received on 14-sep-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves an unknown age female patient who was having fluid in the soft tissue of the right- knee, not being able to bear weight on the right leg, can't put her feet down, it's swollen and constant pain, not being able to walk and pain in the knee (right knee) 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) 2021, the patient started received treatment with hylan g-f 20, sodium hyaluronate (solution for injection) at dose of 6 ml once (with an unknown batch number) for arthritis in right knee.The same day, patient started experiencing pain in right knee and she was in constant pain.It was reported that, before she went to the hcp (healthcare professional), she was able to walk but now, she could not put her feet down, as it was swollen and was in constant pain (pain in extremity and peripheral swelling).She was not being able to walk (gait inability) due to pain, not being able to bear weight on the right leg (weight bearing difficulty) (onset: 2021, latency: few days).She then went to emergency department a week ago where she was diagnosed with the fluid in the soft tissue of the right- knee (joint effusion, aspiration joint; medically significant) (onset: 2021, latency: few days), and department advised to try to let the fluid absorb due to cutting open the knee might be more damaging, she was just given pain medications to treat the pain.She would have an appointment with the orthopedic doctor in (b)(6) 2021, that the pain was too bad and she could not last until (b)(6) 2021.Action taken: not applicable for all.Corrective treatment: pain medications (unspecified) for arthralgia, pain in extremity and peripheral swelling; not reported for rest events.At time of reporting, the outcome was not recovered / not resolved for arthralgia, pain in extremity and peripheral swelling; unknown for rest events.

Event Description

Having fluid in the soft tissue of the right- knee [effusion (r) knee].Having fluid in the soft tissue of the right- knee [arthrocentesis].Not being able to bear weight on the right leg [weight bearing difficulty].Can't put her feet down, it's swollen and constant pain [pain in foot].Can't put her feet down it's swollen and constant pain [swelling of feet].Not being able to walk [unable to walk].Pain in the knee (right knee) [aching (r) knee].Case narrative: initial information received on 14-sep-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves an unknown age female patient who was having fluid in the soft tissue of the right- knee, not being able to bear weight on the right leg, can't put her feet down, it's swollen and constant pain, not being able to walk and pain in the knee (right knee) 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) 2021, the patient started received treatment with hylan g-f 20, sodium hyaluronate (strength: 48mg/6ml) (solution for injection) at dose of 6 ml once (with an unknown batch number) for arthritis in right knee.The same day, patient started experiencing pain in right knee and she was in constant pain.T it was reported that, before she went to the hcp (healthcare professional), she was able to walk but now, she could not put her feet down, as it was swollen and was in constant pain (pain in extremity and peripheral swelling).She was not being able to walk (gait inability) due to pain, not being able to bear weight on the right leg (weight bearing difficulty) (onset: 2021, latency: few days).She then went to emergency department a week ago where she was diagnosed with the fluid in the soft tissue of the right- knee (joint effusion, aspiration joint; medically signficant) (onset: 2021, latency: few days), and department advised to try to let the fluid absorb due to cutting open the knee might be more damaging, she was just given pain medications to treat the pain.She would have an appointment with the orthopedic doctor in oct-2021, that the pain was too bad and she could not last until (b)(6) 2021.Action taken: not applicable for all.Corrective treatment: pain medications (unspecified) for arthralgia, pain in extremity and peripheral swelling; not reported for rest events at time of reporting, the outcome was not recovered / not resolved for arthralgia, pain in extremity and peripheral swelling; unknown for rest events a product technical complaint (ptc) was initiated on 14-sep-2021 for synvisc one.Batch number: unknown; global ptc number: 100158100.The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 27-sep-2021.Follow up information was received on 14-sep-2021 from the other healthcare professional.Global ptc number was added.No significant information was received.Additional information was received on 27-sep-2021 from other healthcare professional.Global ptc results were added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12494120
• MDR Text Key: 272115071
• Report Number: 2246315-2021-00150
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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