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

Lot Number CRSP014A

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

Patient Problems Arthritis (1723); Injection Site Reaction (4562); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 17-mar-2023: this case involves a 60-years old female patient who received medical device hylan g-f 20, sodium hyaluronate [synvisc] and reported she really could not get out of bed, could not weight-bear for a day and significant swelling (left knee).The case will be re-evaluated post-further update regarding concomitant medications, injection technique, post injection routine, batch number details, ptc results.

Event Description

Could not weight-bear [weight bearing difficulty].Could not get out of bed [mobility decreased].Significant swelling (left knee) [injection site joint swelling] ([condition aggravated]).Case narrative: initial information received on 17-feb-2023 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5115110.This case was linked to 2023sa077678, 2023sa086347, 2023sa086400 (multiple devices suspect for same patient).This case involves a 60-years old female patient who received medical device hylan g-f 20, sodium hyaluronate [synvisc] and reported she really could not get out of bed, could not weight-bear and significant swelling (left knee).The patient's past medical history, medical treatment(s), concomitant medication (s) and family history were not provided.She had synvisc in the past and did well with them.No poultry or egg allergy/intolerance.On an unknown date in (b)(6) 2022 , the patient had first injection of synvisc series.In (b)(6) 2022 , the patient received second injection of hylan g-f 20, sodium hyaluronate in left knee (strength: 8 mg/ml) via intra articular route (with an unknown dose, frequency, batch number and expiry date) for bilateral osteoarthritis.Information on batch number and expiry date was requested.The patient reported that after the second injection of synvisc into the bilateral knees last week ((b)(6) 2022 ) she had a very difficult time after the last injections, she really could not get out of bed (mobility decreased) (onset: (b)(6) 2022 , latency: approximately few days) or weight-bear (weight bearing difficulty) (onset: (b)(6) 2022 , latency: approximately few days) for a day.She had significant swelling (injection site joint swelling) (onset: (b)(6) 2022 , latency: approximately few days), no obvious redness.This lasted a couple of days and has improved, certainly not back to pre injection levels but she stated that this was far worse than after the first synvisc series (condition aggravated) (onset: (b)(6) 2022 , latency: approximately few days) 2 weeks ago which she also had some discomfort and intolerance.She has been icing, using over-the-counter anti-inflammatories and tylenol.She did not feel that the knees were back to her pre-injection's level.Action taken: no action taken for all events.Corrective treatment: icing, using over-the-counter anti-inflammatories and tylenol for all events.Outcome: recovering/resolving for injection site joint swelling; recovered/resolved for rest of the events.Seriousness criterion: medically significant for all events.A product technical complaint (ptc) was initiated and the results were pending for the same.

Event Description

Could not weight-bear [weight bearing difficulty].Could not get out of bed [mobility decreased] ([condition aggravated]).Significant swelling (left knee) [injection site joint swelling].Case narrative: initial information received on 17-feb-2023 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5115110.This case was linked to (b)(4).(multiple devices suspect for same patient).This case involves a 60-years old female patient who received medical device hylan g-f 20, sodium hyaluronate [synvisc] and reported she really could not get out of bed, could not weight-bear and significant swelling (left knee).The patient's past medical history, medical treatment(s), concomitant medication (s) and family history were not provided.She had synvisc in the past and did well with them.No poultry or egg allergy/intolerance.On an unknown date in (b)(6)2022, the patient had first injection of synvisc series.In (b)(6)2022, the patient received second injection of hylan g-f 20, sodium hyaluronate in left knee (strength: 16mg/2ml) via intra articular route (with batch number: crsp014a, expiry date: 31-aug-2025, unknown dose, frequency,) for bilateral osteoarthritis.The patient reported that after the second injection of synvisc into the bilateral knees last week (dec-2022) she had a very difficult time after the last injections, she really could not get out of bed (mobility decreased) (onset: (b)(6)2022, latency: approximately few days) or weight-bear (weight bearing difficulty) (onset: (b)(6)2022, latency: approximately few days) for a day.She had significant swelling (injection site joint swelling) (onset(b)(6)2022, latency: approximately few days), no obvious redness.This lasted a couple of days and has improved, certainly not back to pre injection levels but she stated that this was far worse than after the first synvisc series (condition aggravated) (onset: (b)(6)2022, latency: approximately few days) 2 weeks ago which she also had some discomfort and intolerance.She had been icing, using over-the-counter anti-inflammatories and tylenol.She did not feel that the knees were back to her pre-injection's level.Action taken: no action taken for all events corrective treatment: icing, using over-the-counter anti-inflammatories and tylenol for all events outcome: recovering for all events.Seriousness criterion: medically significant for all events.A product technical complaint (ptc) was initiated on (b)(6)2023 for synvisc with global ptc number: (b)(4) (batch: crsp014a, expiry date: 31-aug-2025).The sample of the ptc was not available and ptc was set in process and results were pending for the same.Additional information was received on 17-feb-2023 by quality department: ptc initiating details added; text amended additional information was received on 08-jun-2023 from healthcare professional (quality department).Lot number: crsp014a for (b)(6) along with expiry date: 31-aug-2025 was updated.Text amended accordingly.

Event Description

Could not weight-bear [weight bearing difficulty] could not get out of bed [mobility decreased] ([condition aggravated]) significant swelling (left knee) [injection site joint swelling] case narrative: initial information was received on 17-feb-2023 regarding an unsolicited valid serious case from health authorities of united states under reference mw5115110.This case was linked to 2023sa077678, 2023sa086347, 2023sa086400 (multiple devices suspect for same patient) this case involves a 60-years old female patient who received medical device hylan g-f 20, sodium hyaluronate [synvisc] and reported she really could not get out of bed, could not weight-bear and significant swelling (left knee).The patient's past medical history, medical treatment(s), concomitant medication (s) and family history were not provided.She had synvisc in the past and did well with them.No poultry or egg allergy/intolerance.On an unknown date in (b)(6) 2022, the patient had first injection of synvisc series.In (b)(6)2022, the patient received second injection of hylan g-f 20, sodium hyaluronate in left knee (strength: 16mg/2ml) via intra articular route (with batch number: crsp014a, expiry date: 31-aug-2025, unknown dose, frequency) for bilateral osteoarthritis.The patient reported that after the second injection of synvisc into the bilateral knees last week (b)(6) 2022) she had a very difficult time after the last injections, she really could not get out of bed (mobility decreased) (onset: 28-dec-2022, latency: approximately few days) or weight-bear (weight bearing difficulty) (onset: 28-dec-2022, latency: approximately few days) for a day.She had significant swelling (injection site joint swelling) (onset: 28-dec-2022, latency: approximately few days), no obvious redness.This lasted a couple of days and has improved, certainly not back to pre injection levels but she stated that this was far worse than after the first synvisc series (condition aggravated) (onset: 28-dec-2022, latency: approximately few days) 2 weeks ago which she also had some discomfort and intolerance.She had been icing, using over-the-counter anti-inflammatories and tylenol.She did not feel that the knees were back to her pre-injection's level.Action taken: unknown for all events corrective treatment: icing, using over-the-counter anti-inflammatories and tylenol for all events outcome: recovering for all events.Seriousness criterion: medically significant for all events a product technical complaint (ptc) was initiated on 17-feb-2023 for synvisc with global ptc number: (b)(4) ,(batch: crsp014a, expiry date: 31-aug-2025).The sample of the ptc was not available.Ptc sated: complaint: adverse event preliminary assessment (tj 05jun2023) based on the complaint from intake team, 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.The defect class has been updated to ii.Batch number has been updated to crsp014a on 08jun2023 (tj 08jun2023) investigation (tj 08jun2023) batch # crsp014a, synvisc was manufactured on 20sep2022 with expiration date of 31aug2025 yielding (b)(4) kits.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.Customer sample was not available.Root cause could not be determined.Trend analysis: there are a total of 6 complaints for mother lot crsp0104 and sub-batches.100292748 crsp014a plunger missing 100302463 crsp014a leakage at injection site/ adverse event / syringe issue nos 100310438 crsp014a adverse event 100310443 crsp014a adverse event 100310469 crsp014a adverse event 100332876 crsp014a adverse event there is no quality related defect that would attribute to 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.This review has not indicated any safety issue.Based on investigation and trend analysis, no capa (corrective and preventive action) required.Sanofi will continue to adverse events.Trend analysis will be performed on a periodic basis to determine if a capa is required.The final investigation was completed on 12-jun-2022 with summarized conclusion as no assessment possible.Additional information was received on 17-feb-2023 by quality department: ptc initiating details added; text amended additional information was received on 08-jun-2023 from healthcare professional (quality department).Lot number: crsp014a for ptc (b)(4) along with expiry date: 31-aug-2025 was updated.Text amended accordingly.Additional information was received on 12-jun-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• 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: 16571001
• MDR Text Key: 311560745
• Report Number: 2246315-2023-00025
• 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: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSP014A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female