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

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

Patient Problems Therapeutic Response, Decreased (2271); Arthralgia (2355); No Code Available (3191)

Event Date 09/18/2020

Event Type  Injury  

Event Description

Was almost paralyzed and couldn't walk or do anything [activities of daily living impaired].Was almost paralyzed and couldn't walk or do anything [unable to walk].Pain was so bad that she thought she was going to faint [knee pain].It did not work at all/knee was exactly the same [device ineffective].Case narrative: initial information was received from (b)(6) on 13-jan-2021 regarding an unsolicited valid serious case from a patient via call center.This case involves a (b)(6) years old female patient who received medical device hylan g-f 20, sodium hyaluronate (synvisc one) and was almost paralyzed and couldn't walk or do anything, pain was so bad that she thought she was going to faint and it did not work at all/knee was exactly the same (device ineffective).The patient's past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.The patient saw on facebook that synvisc one was a very good medicine for osteoarthritis.Patient had osteoarthritis in her knees and thumb, but her doctor did not recommend it as it would probably not help her because she had osteoarthritis of the knee level 4.She wanted to try it as her friend told her that she got it once a year and she was fine for at least 9 months.On (b)(6) 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) solution for injection at dose of 6 ml once for osteoarthritis in her knees (level 4) (lot - unknown).Information on batch number was requested.The patient used synvisc one for the first time.On same day, after the injection, the patient had pain which was so bad that she thought that she was going to faint (arthralgia; was leading to intervention).She was almost paralyzed and could not walk (gait inability; was leading to intervention) or do anything (loss of personal independence in daily activities; was leading to intervention and disability).It was unbelievable.Patient had 2 children, and this was worse than childbirth.It did not work at all (device ineffective; latency: unknown).Her knee was exactly the same and it cost her $500.Patient was very upset and disappointed.She had gone for cortisone injections which helped her for a while (maybe a month) while she waited for surgery.It was very depressing.The patient asked that if synvisc-one was only for the knee, not the thumb.Final diagnosis was pain was so bad that she thought she was going to faint, was almost paralyzed and couldn't walk or do anything, and it did not work at all/knee was exactly the same.Action taken: not applicable for all the events.Corrective treatment: cortisone injections for pain was so bad that she thought she was going to faint, and was almost paralyzed and couldn't walk or do anything.The patient outcome is reported as not applicable for device ineffective; recovering for rest of events.A product technical complaint (ptc) was initiated and results were pending for the same.

Event Description

Was almost paralyzed and couldn't walk or do anything [activities of daily living impaired].Was almost paralyzed and couldn't walk or do anything [unable to walk].Pain was so bad that she thought she was going to faint [knee pain].It did not work at all/knee was exactly the same/ did not take any of the pain in my knee [device ineffective].Synvisc was very painful/ injection hurt me very much [pain during injection].Case narrative: initial information was received from canada on 13-jan-2021 regarding an unsolicited valid serious case from a patient via call center.This case involves a 77 years old female patient who received medical device hylan g-f 20, sodium hyaluronate (synvisc one) and was almost paralyzed and couldn't walk or do anything, pain was so bad that she thought she was going to faint, synvisc was very painful/ injection hurt me very much and it did not work at all/knee was exactly the same/ did not take any of the pain in my knee (device ineffective).The patient's past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.The patient saw on facebook that synvisc one was a very good medicine for osteoarthritis.Patient had osteoarthritis in her knees and thumb, but her doctor did not recommend it as it would probably not help her because she had osteoarthritis of the knee level 4.She wanted to try it as her friend told her that she got it once a year and she was fine for at least 9 months.On (b)(6) 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) solution for injection at dose of 6 ml once for osteoarthritis in her knees (level 4) (route and lot - unknown).Information on batch number was requested.The patient used synvisc one for the first time.Reportedly, the hylan g-f 20, sodium hyaluronate was very painful and expensive and did not take any of the pain in her knee (device ineffective), was useless and expensive for her.On the same day, the injection hurt her very much (injection site pain) and after the injection, the patient had pain which was so bad that she thought that she was going to faint (arthralgia; was leading to intervention).She was almost paralyzed and could not walk (gait inability; was leading to intervention) or do anything (loss of personal independence in daily activities; was leading to intervention and disability).It was unbelievable.Patient had 2 children, and this was worse than childbirth.It did not work at all (device ineffective; latency: unknown).Her knee was exactly the same and it cost her $500.Patient was very upset and disappointed.She had gone for cortisone injections which helped her for a while (maybe a month) while she waited for surgery.It was very depressing.The patient asked that if synvisc-one was only for the knee, not the thumb.Action taken: not applicable for all the events.Corrective treatment: cortisone injections for pain was so bad that she thought she was going to faint, was almost paralyzed and couldn't walk or do anything; unknown for synvisc was very painful/ injection hurt me very much; not reported for rest of the events.The patient outcome is reported as not applicable for device ineffective; unknown for injection site pain, recovering for rest of events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one, batch number: unknown; with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformance) 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 has not indicated any safety issue.Sanofi will continue to monitor complaints as stated in sop (b)(4)."product event handling" to determine if a capa is required.Final investigation was completed on (b)(6) 2021.Follow-up was received on 13-jan-2021 from other healthcare professional.Global ptc number was added.No significant information received.Additional information was received on 12-jan-2021 from the patient.Event added for synvisc was very painful/ injection hurt me very much.Event verbatim updated for it did not work at all/knee was exactly the same/ did not take any of the pain in my knee.Clinical course was updated.Text amended accordingly.Additional information was received on 21-jan-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

Event Description

Was almost paralyzed and couldn't walk or do anything [activities of daily living impaired] was almost paralyzed and couldn't walk or do anything [unable to walk] pain was so bad that she thought she was going to faint [knee pain] it did not work at all/knee was exactly the same/ did not take any of the pain in my knee [device ineffective] synvisc was very painful/ injection hurt me very much [pain during injection] case narrative: initial information was received from canada on 13-jan-2021 regarding an unsolicited valid serious case from a patient via call center.This case involves a 77 years old female patient who received medical device hylan g-f 20, sodium hyaluronate (synvisc one) and was almost paralyzed and couldn't walk or do anything, pain was so bad that she thought she was going to faint, synvisc was very painful/ injection hurt me very much and it did not work at all/knee was exactly the same/ did not take any of the pain in my knee (device ineffective).The patient's past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.The patient saw on facebook that synvisc one was a very good medicine for osteoarthritis.Patient had osteoarthritis in her knees and thumb, but her doctor did not recommend it as it would probably not help her because she had osteoarthritis of the knee level 4.She wanted to try it as her friend told her that she got it once a year and she was fine for at least 9 months.On (b)(6) 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) solution for injection at dose of 6 ml once for osteoarthritis in her knees (level 4) (lot - unknown).Information on batch number was requested.The patient used synvisc one for the first time.Reportedly, the hylan g-f 20, sodium hyaluronate was very painful and expensive and did not take any of the pain in her knee (device ineffective), was useless and expensive for her.On the same day, the injection hurt her very much (injection site pain) and after the injection, the patient had pain which was so bad that she thought that she was going to faint (arthralgia; was leading to intervention).She was almost paralyzed and could not walk (gait inability; was leading to intervention) or do anything (loss of personal independence in daily activities; was leading to intervention and disability).It was unbelievable.Patient had 2 children, and this was worse than childbirth.It did not work at all (device ineffective; latency: unknown).Her knee was exactly the same and it cost her (b)(6).Patient was very upset and disappointed.She had gone for cortisone injections which helped her for a while (maybe a month) while she waited for surgery.It was very depressing.The patient asked that if synvisc-one was only for the knee, not the thumb.Action taken: not applicable for all the events.Corrective treatment: cortisone injections for pain was so bad that she thought she was going to faint, was almost paralyzed and couldn't walk or do anything; unknown for synvisc was very painful/ injection hurt me very much; not reported for rest of the events.The patient outcome is reported as not applicable for device ineffective; unknown for injection site pain, recovering for rest of events a product technical complaint (ptc) was initiated with global ptc number (b)(4) and results were pending for the same.Follow-up was received on 13-jan-2021 from other healthcare professional.Global ptc number was added.No significant information received.Additional information was received on 12-jan-2021 from the patient.Event added for synvisc was very painful/ injection hurt me very much.Event verbatim updated for it did not work at all/knee was exactly the same/ did not take any of the pain in my knee.Clinical course was 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: 11176870
• MDR Text Key: 232532700
• Report Number: 2246315-2021-00025
• 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,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

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: 01/15/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/22/2021; 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability