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

Lot Number 9RSL040B

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

Patient Problem Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Unable to walk [unable to walk].Lost weight [lost weight].Hurts sometimes [aching (r) knee].Case narrative: initial information received on 19-feb-2024 regarding a solicited valid serious case received from a 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.This case involves elderly female patient who was unable to walk, lost weight and hurts sometimes 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6ml in right knee at a dose of 6 ml 1x(once) (lot: 9rsl040b; expiry date, route and indication - unknown).Patient mentioned on a an unknown date in 2021, and unknown latency she was not having trouble with her knee yet, just a little bit but was not taking any injections yet.Patient said that she was unable to walk (gait inability; seriousness criteria: intervention required) therefore had a knee (right) replacement.The doctor also told the patient that the other knee won't last long.Patient said she lost weight (weight decreased) and that it hurts sometimes(arthralgia).No other information was provided.Action taken: knee (right) replacement as a corrective treatment was received for the event gait inability and was not reported for rest events.At time of reporting, the outcome was recovered on an unknown date for the event gait inability, was unknown for rest events.Reporter causality: not reported for all events.Company causality: not reportable for all events.

Event Description

Unable to walk [unable to walk].Lost weight [lost weight].Hurts sometimes [aching (r) knee].Case narrative: initial information received on 19-feb-2024 regarding a solicited valid serious case received from a 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.This case involves "an approximately" 72 year old female patient who was unable to walk, lost weight and hurts sometimes 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution) in right knee at a dose of 6 ml 1x(once) (strength 48 mg/6ml, lot: 9rsl040b; expiry date, route and indication - unknown).Patient mentioned on an unknown date in 2021 (unknown latency) she was not having trouble with her knee yet, just a little bit but was not taking any injections yet.Patient said that she was unable to walk (gait inability; seriousness criteria: intervention required) therefore had a knee (right) replacement.The doctor also told the patient that the other knee won't last long.Patient said she lost weight (weight decreased, onset date: 2021, latency: unknown) and that it hurts sometimes (arthralgia, onset date: 2021, latency: unknown).No other information was provided.Action taken: not applicable for all events.Corrective treatment: knee (right) replacement for the event gait inability and not reported for rest of the events.At time of reporting, the outcome was recovered on an unknown date for the event gait inability, was unknown for rest of the events.Reporter causality: not reported for all events.Company causality: not reportable for all events.A product technical complaint (ptc) was initiated on 20-feb-2024 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: 9rsl040b) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc states: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.Investigation: the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive action) is required.Reopened: lot number added.(06mar24) batch number 9rsl040b, synvisc was manufactured on 04oct2019 with expiration date of 30sep2022 yielding (b)(4) singles.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.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 nonconforming material or product process.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Trend analysis: there is twenty four (24) complaints for mother lot 9rsl040 and sub-batches.Event (b)(4) 9rsl040 difficult to sue/dispensing the product (b)(4) 9rsl040 without/not enough effect (b)(4) 9rsl040c without/not enough effect (b)(4) 9rsl040b other pharmacovigilance event (b)(4) 9rsl040b other pharmacovigilance event (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b other pharmacovigilance event (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040c other pharmacovigilance event (b)(4) 9rsl040 other pharmacovigilance event (b)(4) 9rsl040 other pharmacovigilance event (b)(4) 9rsl040 other pharmacovigilance event (b)(4) 9rsl040b other pharmacovigilance event (b)(4) 9rsl040b other adverse reaction (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b without/not enough effect (b)(4) 9rsl040b without/not enough effect based on investigation and trend analysis, no capa required.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis "product event handling" to determine if a capa(corrective and preventive action) is required.There is no quality related defect that would attribute to a malfunction, death, or serious injury.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.Final investigation complete date: 11-mar-2024 the summarized conclusion for this case no assessment is possible.Additional information was received on 11-mar-2024 from the quality department.Ptc details added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 18785545
• MDR Text Key: 336296619
• Report Number: 2246315-2024-00015
• 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,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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 Lot Number: 9RSL040B
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female