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

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

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

Event Date 11/18/2020

Event Type  Injury  

Event Description

Right above my knee it's huge/swelling in right knee [swelling of r knee] pain in right knee [aching (r) knee] mild effusion post injection [joint effusion] case narrative: based on additional information received on 14-dec-2020 from healthcare professional, the case was medically confirmed.Additionally, the case initially considered non serious was upgraded to serious (seriousness criteria of intervention required added) initial information was received from canada on 18-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case is linked to case 2020sa328900 (multiple devices, 1st injection of synvisc series).This case involves an approximately 53 years old female patient who experienced right above my knee it's huge/swelling in right knee, pain in right knee, mild effusion post injection while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, vaccination(s), family history and concomitant medications were not provided.Past drugs included cortisone injections in the right knee in (b)(6) and (b)(6) 2020 and cingal in the left knee with some good success.On (b)(6) 2020, the patient initiated treatment with hylan g-f 20, sodium hyaluronate solution for injection at dose of 2 ml thrice in the right knee for grade iii osteoarthritis (route, batch number: unknown).Information on the batch number was requested.On 18-nov-2020, the patient received second hylan g-f 20, sodium hyaluronate injection.On the same day, after the second injection, after latency of 7 days, the patient had pain in right knee (mild) (arthralgia), huge swelling right above her knee (mild) (joint swelling) and mild effusion post injection (joint effusion).Synvisc seemed to bother and the patient was a little more uncomfortable than she was prior to her first injection of synvisc.Cortisone was injected on the second of 3 injections of synvisc (seriousness criteria: intervention required).This was patient's third injection of cortisone within last 12 months.Upon completion, all her symptoms were resolved.It was reported that synvisc did contribute to the adverse events and they were not related to any pre-existing conditions.On 25-nov-2020, patient's knee pain had not really settled down all that much.Her old x-rays back from january were reviewed, in which there was not much going on, but there were slight irregularities over the lateral side of her knee.Patient would get more films done since this was about 11 months ago.The mri (magnetic resonance imaging) scan indicated lateral compartment osteoarthritic changes with some cystic changes.However, the x-rays really didn't confirm this.The third injection of synvisc was carried out with local anesthetic and completed without any incidences.It did take a while but she did feel better with this.It was also reported that patient's presentation would be reviewed in 3 weeks time and if conservative management fails, the patient might be a candidate for a knee replacement surgery, under the circumstances.Action taken: no action taken for all the events corrective treatment: cortisone injection for all the events outcome: recovered for all the events on(b)(6) 2020 a product technical complaint (ptc) was initiated on 18-nov-2020 for synvisc for unknown batch number and global ptc number: 100082752 the product lot number was not provided; therefore, a batch record review was not possible.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-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 25-nov-2020 reporter causality: related for all the events additional information was received on 18-nov-2020 from a patient.As reported term was updated to right above my knee it's huge/swelling in right knee, its outcome and linking was also updated.Event added- pain in right knee.Dosing details for suspect product was updated.Clinical course was updated.Text was amended accordingly.Additional information was received on 25-nov-2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.Additional information was received on 14-dec-2020 from healthcare professional.Outcomes updated and intensity, reporter causality and recovery date added for arthralgia and joint swelling.Overall action taken updated.Additional event of mild effusion post injection added.Indication added.Past drugs added.Laboratory data added.Case was medically confirmed.Case upgraded to serious (seriousness criteria of intervention required added).Text amended accordingly.

Event Description

Right above my knee it's huge/swelling in right knee [swelling of r knee]; pain in right knee [aching (r) knee]; mild effusion post injection [joint effusion].Case narrative: based on additional information received on 14-dec-2020 from healthcare professional, the case was medically confirmed.Additionally, the case initially considered non serious was upgraded to serious (seriousness criteria of intervention required added).Initial information was received from canada on 18-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case is linked to case (b)(6) (multiple devices, 1st injection of synvisc series).This case involves an approximately 53 years old female patient who experienced right above my knee it's huge/swelling in right knee, pain in right knee, mild effusion post injection while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, vaccination(s), family history and concomitant medications were not provided.Past drugs included cortisone injections in the right knee in (b)(6) 2020 and cingal in the left knee with some good success.On (b)(6) 2020, the patient initiated treatment with hylan g-f 20, sodium hyaluronate solution for injection at dose of 2 ml thrice in the right knee for grade iii osteoarthritis (route, batch number: unknown).Information on the batch number was requested.On (b)(6) 2020, the patient received second hylan g-f 20, sodium hyaluronate injection.On the same day, after the second injection, after latency of 7 days, the patient had pain in right knee (mild) (arthralgia), huge swelling right above her knee (mild) (joint swelling) and mild effusion post injection (joint effusion).Synvisc seemed to bother and the patient was a little more uncomfortable than she was prior to her first injection of synvisc.Cortisone was injected on the second of 3 injections of synvisc (seriousness criteria: intervention required).This was patient's third injection of cortisone within last 12 months.Upon completion, all her symptoms were resolved.It was reported that synvisc did contribute to the adverse events and they were not related to any pre-existing conditions.On (b)(6) 2020, patient's knee pain had not really settled down all that much.Her old x-rays back from (b)(6) were reviewed, in which there was not much going on, but there were slight irregularities over the lateral side of her knee.Patient would get more films done since this was about 11 months ago.The mri (magnetic resonance imaging) scan indicated lateral compartment osteoarthritic changes with some cystic changes.However, the x-rays really didn't confirm this.The third injection of synvisc was carried out with local anesthetic and completed without any incidences.It did take a while but she did feel better with this.It was also reported that patient's presentation would be reviewed in 3 weeks time and if conservative management fails, the patient might be a candidate for a knee replacement surgery, under the circumstances.It was reported that patient was not recovered from right above my knee it's huge/swelling in right knee, pain in right knee, mild effusion post injection.Action taken: no action taken for all the events.Corrective treatment: cortisone injection for all the events.Outcome: not recovered for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.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-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 25-nov-2020.Reporter causality: related for all the events.Additional information was received on 18-nov-2020 from a patient.As reported term was updated to right above my knee it's huge/swelling in right knee, its outcome and linking was also updated.Event added- pain in right knee.Dosing details for suspect product was updated.Clinical course was updated.Text was amended accordingly.Additional information was received on 25-nov-2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.Additional information was received on 14-dec-2020 from healthcare professional.Outcomes updated and intensity, reporter causality and recovery date added for arthralgia and joint swelling.Overall action taken updated.Additional event of mild effusion post injection added.Indication added.Past drugs added.Laboratory data added.Case was medically confirmed.Case upgraded to serious (seriousness criteria of intervention required added).Text amended accordingly.Additional information was received on 15-jan-2021 from the non-healthcare professional.Outcome for all the events updated to not recovered.Clinical course updated and text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11044072
• MDR Text Key: 227476431
• Report Number: 2246315-2020-00173
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2021

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention