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

Lot Number DRSP015B

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

Patient Problems Arthritis (1723); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 03/05/2024

Event Type  Injury  

Event Description

Awoke in tears, she states that she could not bend her knees whatsoever and was barely ambulatory [joint range of motion decreased].Not able to walk for 4 days,required a wheelchair, as she could not walk/barely ambulatory [gait inability].Pseudosepsis after she had the dose of synvisc [pseudoseptic arthritis] ([stiff knees]).Did not get any benefit in either knee from the synvisc treatment with no reported adverse event [device ineffective].Case narrative: initial information received on 27-mar-2024 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves a 64 years old female patient who awoke in tears, she states that she could not bend her knees whatsoever and was barely ambulatory, was not able to walk for 4 days, required a wheelchair, as she could not walk/barely ambulatory, had pseudosepsis after she had the dose of synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Patient states that she has received synvisc multiple times, over the course of many years but had no issues.Her last dose of synvisc was on (b)(6) 2022.She did not have any issues after the injection was given and the benefits lasted for almost 2 years.She returned to the same provider for synvisc treatment in (b)(6) 2024.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing baker's cyst.On (b)(6) 2024, the patient received first hylan g-f 20, sodium hyaluronate injection of series in right knee of strength: 16mg/2ml, at a dose of 16mg once for osteoarthritis (route: unknown).On same day, in the evening, she noticed that both knees already were feeling very stiff (joint stiffness).On (b)(6) 2024 (next morning), after latency of 1 day, the patient awoke in tears and could not bend her knees whatsoever and was barely ambulatory (joint range of motion decreased and gait inability).So, she contacted her provider on same day, which was a thursday ((b)(6) 2024) and doctor did not see patients on fridays, so she had to wait until monday, (b)(6) 2024 to see him.At that time, she required a wheelchair, as she could not walk (gait inability).Her provider initially suspected a blood clot in her left leg, due to the increased warmth and severe swelling (feeling hot and peripheral swelling; onset date: 2024, latency: unknown), but imaging ruled that possibility out.She was diagnosed by her doctor as having pseudosepsis (arthritis; onset: (b)(6) 2024 and latency: 6 days) and was not able to walk for 4 days.She was started on oral steroids on (b)(6) 2024 and her condition has resolved, although she did not get any benefit in either knee from the synvisc treatment (device ineffective; onset date: 2024 and latency: unknown).Batch number of last used (hylan g-f 20, sodium hyaluronate) on (b)(6) 2024 was (drsp015b), patient had no information on the expiration date of the same.It was reported that the patient had refused to take injection 2 and 3 because of the adverse effect that she experienced with the first injection of synvisc.Patient wanted to know what was the difference between the synvisc that she took last 2022 and the synvisc that she took last (b)(6) 2024.Patient wanted to know if sanofi changed the formulation of synvisc that resulted from her having the adverse effect after her dose.Consumer asked initially if synvisc was bought or sold in 2022 because she read that on-line.No documentation found that formulation has been changed, most recent pi (package insert) update was 2023.Action taken: drug withdrawn for pseudosepsis , could not walk/ barely ambulatory and joint range of motion decreased.Corrective treatment: oral steroids for arthritis; wheelchair for gait inability.At time of reporting, the outcome was recovered on an unknown date in (b)(6) 2024 for all the events seriousness criteria: disability for gait inability; intervention required for arthritis and joint range of motion decreased.

Event Description

Awoke in tears, she states that she could not bend her knees whatsoever and was barely ambulatory [joint range of motion decreased] not able to walk for 4 days,required a wheelchair, as she could not walk/barely ambulatory [gait inability] pseudosepsis after she had the dose of synvisc [pseudoseptic arthritis] ([stiff knees]) did not get any benefit in either knee from the synvisc treatment with no reported adverse event [device ineffective] case narrative: initial information received on 27-mar-2024 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple devices suspect for same patient) and (b)(4) (cluster) this case involves a 64 years old female patient who awoke in tears, she states that she could not bend her knees whatsoever and was barely ambulatory, was not able to walk for 4 days, required a wheelchair, as she could not walk/barely ambulatory, had pseudosepsis after she had the dose of synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Patient states that she has received synvisc multiple times, over the course of many years but had no issues.Her last dose of synvisc was on (b)(6) 2022.She did not have any issues after the injection was given and the benefits lasted for almost 2 years.She returned to the same provider for synvisc treatment in february of 2024.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing baker's cyst.On (b)(6) 2024, the patient received first hylan g-f 20, sodium hyaluronate injection of series in right knee of strength: 16mg/2ml, at a dose of 16mg once for osteoarthritis (route: unknown).On same day, in the evening, she noticed that both knees already were feeling very stiff (joint stiffness).On (b)(6) 2024 (next morning), after latency of 1 day, the patient awoke in tears and could not bend her knees whatsoever and was barely ambulatory (joint range of motion decreased and gait inability).So, she contacted her provider on same day, which was a thursday ((b)(6) 2024) and doctor did not see patients on fridays, so she had to wait until monday, (b)(6) 2024 to see him.At that time, she required a wheelchair, as she could not walk (gait inability).Her provider initially suspected a blood clot in her left leg, due to the increased warmth and severe swelling (feeling hot and peripheral swelling; onset date: 2024, latency: unknown), but imaging ruled that possibility out.She was diagnosed by her doctor as having pseudosepsis (arthritis; onset: (b)(6) 2024 and latency: 6 days) and was not able to walk for 4 days.She was started on oral steroids on (b)(6) 2024 and her condition has resolved, although she did not get any benefit in either knee from the synvisc treatment (device ineffective; onset date: 2024 and latency: unknown).Batch number of last used (hylan g-f 20, sodium hyaluronate) on (b)(6) 2024 was drsp015b) and expiry date: 31-jul-2026.It was reported that the patient had refused to take injection 2 and 3 because of the adverse effect that she experienced with the first injection of synvisc.Patient wanted to know what was the difference between the synvisc that she took last 2022 and the synvisc that she took last (b)(6) 2024.Patient wanted to know if sanofi changed the formulation of synvisc that resulted from her having the adverse effect after her dose.Consumer asked initially if synvisc was bought or sold in 2022 because she read that on-line.No documentation found that formulation has been changed, most recent pi (package insert) update was 2023.Action taken: drug withdrawn for pseudosepsis , could not walk/ barely ambulatory and joint range of motion decreased.Corrective treatment: oral steroids for arthritis; wheelchair for gait inability.At time of reporting, the outcome was recovered on an unknown date in mar-2024 for joint range of motion decreased, gait inability and arthritis seriousness criteria: disability for gait inability; intervention required for arthritis and joint range of motion decreased.A product technical complaint (ptc) was initiated on 26-mar-2024 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: drsp015b and expiry date: 31-jul-2026) with global ptc number: (b)(4).The sample of the ptc was not available.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.(rc 28mar24) investigation: (rc (b)(6) 2024) batch number drsp015b, synvisc was manufactured on (b)(6) 2023 with expiration date of 31jul2026 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.Trend analysis: there are three (3) complaints for mother lot drsp015 and sub-batches.Based on investigation and trend analysis, no capa (corrective action and preventive action) required.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis to determine if a capa is required.This review has not indicated any safety issue.The final investigation was completed on 08-apr-2024 with summarized conclusion as no assessment possible.Additional information was received on 26-mar-2024 from other health care professional (from quality department): global ptc number and suspect expiry date added.Text amended accordingly.Additional information was received on 08-apr-2024 from other health care professional (from quality department): global ptc number and suspect expiry date added.Text amended accordingly.

Event Description

Awoke in tears, she states that she could not bend her knees whatsoever and was barely ambulatory [joint range of motion decreased] not able to walk for 4 days,required a wheelchair, as she could not walk/barely ambulatory [gait inability] pseudosepsis after she had the dose of synvisc [pseudoseptic arthritis] ([stiff knees]) did not get any benefit in either knee from the synvisc treatment with no reported adverse event [device ineffective].Case narrative: initial information received on 27-mar-2024 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple devices suspect for same patient) and (b)(4).(cluster) this case involves a 64 years old female patient who awoke in tears, she states that she could not bend her knees whatsoever and was barely ambulatory, was not able to walk for 4 days, required a wheelchair, as she could not walk/barely ambulatory, had pseudosepsis after she had the dose of synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Patient states that she has received synvisc multiple times, over the course of many years but had no issues.Her last dose of synvisc was on 11apr2022.She did not have any issues after the injection was given and the benefits lasted for almost 2 years.She returned to the same provider for synvisc treatment in february of 2024.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing baker's cyst.On (b)(6) 2024, the patient received first hylan g-f 20, sodium hyaluronate injection of series in right knee of strength: 16mg/2ml, at a dose of 16mg once for osteoarthritis (route: unknown).On same day, in the evening, she noticed that both knees already were feeling very stiff (joint stiffness).On 29-feb-2024 (next morning), after latency of 1 day, the patient awoke in tears and could not bend her knees whatsoever and was barely ambulatory (joint range of motion decreased and gait inability).So, she contacted her provider on same day, which was a thursday (29-feb-2024) and doctor did not see patients on fridays, so she had to wait until monday, 03-mar-2024 to see him.At that time, she required a wheelchair, as she could not walk (gait inability).Her provider initially suspected a blood clot in her left leg, due to the increased warmth and severe swelling (feeling hot and peripheral swelling; onset date: 2024, latency: unknown), but imaging ruled that possibility out.She was diagnosed by her doctor as having pseudosepsis (arthritis; onset: 05-mar-2024 and latency: 6 days) and was not able to walk for 4 days.She was started on oral steroids on 05-mar-2024 and her condition has resolved, although she did not get any benefit in either knee from the synvisc treatment (device ineffective; onset date: 2024 and latency: unknown).Batch number of last used (hylan g-f 20, sodium hyaluronate) on 28-feb-2024 was drsp015b) and expiry date: 31-jul-2026.It was reported that the patient had refused to take injection 2 and 3 because of the adverse effect that she experienced with the first injection of synvisc.Patient wanted to know what was the difference between the synvisc that she took last 2022 and the synvisc that she took last 28-feb-2024.Patient wanted to know if sanofi changed the formulation of synvisc that resulted from her having the adverse effect after her dose.Consumer asked initially if synvisc was bought or sold in 2022 because she read that on-line.No documentation found that formulation has been changed, most recent pi (package insert) update was 2023.Action taken: drug withdrawn for pseudosepsis , could not walk/ barely ambulatory and joint range of motion decreased.Corrective treatment: oral steroids for arthritis; wheelchair for gait inability.At time of reporting, the outcome was recovered on an unknown date in mar-2024 for joint range of motion decreased, gait inability and arthritis seriousness criteria: disability for gait inability; intervention required for arthritis and joint range of motion decreased.A product technical complaint (ptc) was initiated on 26-mar-2024 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: drsp015b and expiry date: 31-jul-2026) with global ptc number: (b)(4).The sample was not available and ptc was set in process.Additional information was received on 26-mar-2024 from other health care professional (from quality department): global ptc number and suspect expiry date 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: 19040320
• MDR Text Key: 339333854
• Report Number: 2246315-2024-00023
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2024

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 Operator: Health Professional
• Device Lot Number: DRSP015B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/09/2024; 04/11/2024
• 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): Required Intervention; Disability
• Patient Sex: Female