MAUDE Adverse Event Report: SYNVISC ONE; MOZ

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Therapeutic Response, Decreased (2271); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 25-jan-2021: this case concerns a patient who was on treatment with synvisc one and was unable to walk for two to three months.Based on limited information, the plausible causal role of the device cannot be denied, however the underlying condition of osteoarthritis could also be a confounding factor.Further, detailed information regarding other medications, clinical course of the event would aid in comprehensive assessment of the case.

Event Description

Unable to walk for two to three months [unable to walk].Left knee became swollen, red, painful [injection site joint swelling].Left knee became swollen, red, painful [injection site joint pain] ([device ineffective]).Left knee became swollen, red, painful [injection site joint redness].Caused water on his knee (left) [injection site joint effusion].Case narrative: initial information received on 18-jan-2021 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc one.The case is linked to (b)(4) (multiple devices for right knee).This case involves adult male patient who experienced unable to walk for two to three months, left knee became swollen, red, painful and caused water on his knee (left), while he using with the use of medical device 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, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once via unknown route in left knee (lot - unknown) for osteoarthritis.Information on the batch number was requested.It was reported that injection that it did not work for him and there was lack of efficacy (device ineffective; onset, latency: unknown).On an unknown date, once receiving the injections (after unknown latency), patient's knee became swollen (injection site joint swelling), red (injection site joint erythema), painful (injection site joint pain) and he was unable to walk for two to three months (gait inability; event assessed as serious due to disability) and it caused water on his knee (injection site joint effusion).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment.Outcome: unknown for injection site joint erythema and injection site joint effusion, recovered for rest of the events.Reporter causality: not reported for injection site joint erythema and injection site joint effusion, related for rest of the events.Company causality: not reportable for all events.

Event Description

Unable to walk for two to three months [unable to walk].Left knee became swollen, red, painful [injection site joint swelling].Left knee became swollen, red, painful [injection site joint pain] ([device ineffective]).Left knee became swollen, red, painful [injection site joint redness].Caused water on his knee (left) [injection site joint effusion].Case narrative: initial information received on 18-jan-2021 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.The case is linked to case (b)(4) (multiple devices for right knee).This case involves adult male patient who experienced unable to walk for two to three months, left knee became swollen, red, painful and caused water on his knee (left), while he using with the use of medical device 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, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once via unknown route in left knee (lot - unknown) for osteoarthritis.Information on the batch number was requested.It was reported that injection that it did not work for him and there was lack of efficacy (device ineffective; onset, latency: unknown).On an unknown date, once receiving the injections (after unknown latency), patient's knee became swollen (injection site joint swelling), red (injection site joint erythema), painful (injection site joint pain) and he was unable to walk for two to three months (gait inability; event assessed as serious due to disability) and it caused water on his knee (injection site joint effusion).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment.Outcome: unknown for injection site joint erythema and injection site joint effusion, recovered for rest of the events.Reporter causality: not reported for injection site joint erythema and injection site joint effusion, related for rest of the events.Company causality: not reportable for all events.A product technical complaint (ptc) was initiated on 19-jan-2021 for synvisc one 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: 22-jan-2021 (for 100096212), 27-jan-2021 (for 100096550).Additional information was received on 19-jan-2021 (non-significant), 22-jan-2021 (significant), 27-jan-2021 (significant) (processed with clock start date of 22-jan-2021) from healthcare professional.Global ptc number and its results were added.Text amended accordingly.

Event Description

Unable to walk for two to three months [unable to walk] left knee became swollen, red, painful [injection site joint swelling] left knee became swollen, red, painful [injection site joint pain] ([device ineffective]) left knee became swollen, red, painful [injection site joint redness] caused water on his knee (left) [injection site joint effusion] case narrative: initial information received on 18-jan-2021 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada study title: patient support program involving synvisc one.The case is linked to case (b)(4) (multiple devices for right knee).This case involves adult male patient who experienced unable to walk for two to three months, left knee became swollen, red, painful and caused water on his knee (left), while he using with the use of medical device 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, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once via unknown route in left knee (lot - unknown) for osteoarthritis.Information on the batch number was requested.It was reported that injection that it did not work for him and there was lack of efficacy (device ineffective; onset, latency: unknown).On an unknown date, once receiving the injections (after unknown latency), patient's knee became swollen (injection site joint swelling), red (injection site joint erythema), painful (injection site joint pain) and he was unable to walk for two to three months (gait inability; event assessed as serious due to disability) and it caused water on his knee (injection site joint effusion).Action taken: not applicable for all events it was not reported if the patient received a corrective treatment.Outcome: unknown for injection site joint erythema and injection site joint effusion, recovered for rest of the events reporter causality: not reported for injection site joint erythema and injection site joint effusion, related for rest of the events.Company causality: not reportable for all events a product technical complaint (ptc) was initiated on 19-jan-2021 for synvisc one for unknown batch number and global ptc number: 100096212.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: 22-jan-2021 additional information was received on 19-jan-2021 (non-significant), 22-jan-2021 (significant), 27-jan-2021 (significant) (processed with clock start date of 22-jan-2021) from healthcare professional.Global ptc number and its results were added.Text amended accordingly.Follow up was received on 01-feb-2021 from healthcare professional.Global ptc number 100096550 was cancelled.Text amended accordingly.

Event Description

Unable to walk for two to three months [unable to walk] left knee became swollen, red, painful [injection site joint swelling] left knee became swollen, red, painful [injection site joint pain] ([device ineffective]) left knee became swollen, red, painful [injection site joint redness] caused water on his knee (left) [injection site joint effusion] 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 18-jan-2021 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada study title: patient support program involving synvisc one.The case is linked to case (b)(4) (multiple devices for right knee).This case involves adult male patient who experienced unable to walk for two to three months, left knee became swollen, red, painful and caused water on his knee (left), while he using with the use of medical device 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, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once via unknown route in left knee (lot - unknown) for osteoarthritis.Information on the batch number was requested.It was reported that injection that it did not work for him and there was lack of efficacy (device ineffective; onset, latency: unknown).On an unknown date, once receiving the injections (after unknown latency), patient's knee became swollen (injection site joint swelling), red (injection site joint erythema), painful (injection site joint pain) and he was unable to walk for two to three months (gait inability; event assessed as serious due to disability) and it caused water on his knee (injection site joint effusion).Action taken: not applicable for all events it was not reported if the patient received a corrective treatment.Outcome: unknown for injection site joint erythema and injection site joint effusion, recovered for rest of the events reporter causality: not reported for injection site joint erythema and injection site joint effusion, related for rest of the events.Company causality: not reportable for all events a product technical complaint (ptc) was initiated on 19-jan-2021 for synvisc one for unknown batch number and global ptc number: 100096212.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: 22-jan-2021 the global ptc number: 100096212 has been reopened due to incomplete information.Additional information was received on 19-jan-2021 (non-significant), 22-jan-2021 (significant), 27-jan-2021 (significant) (processed with clock start date of 22-jan-2021) from healthcare professional.Global ptc number and its results were added.Text amended accordingly.Follow up was received on 01-feb-2021 from healthcare professional.Global ptc number (b)(4) was cancelled.Text amended accordingly.Follow up was received on 01-feb-2021 from healthcare professional.Global ptc number (b)(4) was cancelled.Text amended accordingly.Follow up information was received on 20-feb-2021.Information regarding global ptc number: 100096212 added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• MDR Report Key: 11228334
• MDR Text Key: 232637014
• Report Number: 2246315-2021-00034
• 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,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability