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

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

Patient Problems Hypoesthesia (2352); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Type  Injury  

Event Description

Numbness of great toe [numbness in toes].Pain and swelling in lower leg [leg pain].Pain and swelling in lower leg [unilateral leg swelling].Pain and swelling in knee [knee pain].Pain and swelling in knee [knee swelling].Laryngitis [laryngitis].Case narrative: initial information received on 29-jan-2020 from united states regarding an unsolicited valid serious case received from a physician.This case involves an unknown age female patient who experienced pain and swelling in knee (latency 2 weeks), numbness of great toe, pain and swelling in lower leg and laryngitis (latency unknown), while she was 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 an unknown date in december(year not specified), the patient received treatment with hylan g-f 20, sodium hyaluronate injection in unspecified knee, at a dose of 6 ml, once via intraarticular route (with an unknown batch number) for knee pain.Information on batch number was requested.On an unknown date, 2 weeks post injection, patient had pain and swelling (intervention required) and was given medrol pack that did not reduce the pain and was also given pain meds.It was reported that patient was then seen 2 weeks later with pain and swelling in knee and lower leg, numbness of great toe (intervention required) and developed laryngitis (latency unknown).No more information provided.Action taken: not applicable for all events.Corrective treatment: not reported for laryngitis; medrol pack and pain meds for rest events.Outcome: not recovered for pain and swelling in knee; unknown for rest events.A product technical complaint was initiated and results were pending for the same.

Event Description

Numbness of great toe [numbness in toes].Pain and swelling in lower leg [leg pain] pain and swelling in lower leg [unilateral leg swelling] pain and swelling in knee [knee pain].Pain and swelling in knee [knee swelling].Laryngitis [laryngitis].Case narrative: initial information received on 29-jan-2020 from united states regarding an unsolicited valid serious case received from a physician.This case involves an unknown age female patient who experienced pain and swelling in knee (latency 2 weeks), numbness of great toe, pain and swelling in lower leg and laryngitis (latency unknown), while she was 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 an unknown date on (b)(6) (year not specified), the patient received treatment with hylan g-f 20, sodium hyaluronate injection (liquid solution) in unspecified knee, at a dose of 6 ml, once via intraarticular route (with an unknown batch number) for knee pain.Information on batch number was requested.On an unknown date, 2 weeks post injection, patient had pain and swelling (intervention required) and was given medrol pack that did not reduce the pain and was also given pain meds.It was reported that patient was then seen 2 weeks later with pain and swelling in knee and lower leg, numbness of great toe (intervention required) and developed laryngitis (latency unknown).No more information provided.Action taken: not applicable for all events.Corrective treatment: not reported for laryngitis; medrol pack and pain meds for rest events.Outcome: not recovered for pain and swelling in knee; unknown for rest events.A product technical complaint (ptc) was initiated on 31-jan-2020 for synvisc one.Batch number: unknown; global ptc number: 100020137.The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa 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 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 adverse events to determine if a capa was required.Investigation complete date: 01-mar-2020.Follow up information received on 31-jan-2020 from other healthcare professional.Global ptc number added.Text amended accordingly.Follow up information received on 12-feb-2020 from other healthcare professional.No new information received.Additional information was received on 01-mar-2020 from other healthcare professional (genzyme event management group).Global ptc number and its 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: 9700284
• MDR Text Key: 192423674
• Report Number: 2246315-2020-00030
• 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: 03/06/2020

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: 02/12/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention