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

Lot Number ARSP003C

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

Patient Problems Arthritis (1723); Bacterial Infection (1735); Ambulation Difficulties (2544)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment on 05-mar-2022: this case involves a (b)(6) male patient who experienced bilateral septic arthritis in the knees after infiltration with synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Bilateral septic arthritis in the knees after infiltration with synvisc [septic arthritis].Case narrative: initial information received on 25-feb-2022 from italy regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) male patient who experienced bilateral septic arthritis in the knees after infiltration with synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].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 (strength, dosage, frequency, route, batch number, indication, expiration date: unknown).On (b)(6) 2022 (latency: unknown), the patient developed bilateral septic arthritis in the knees after infiltration with synvisc (arthritis bacterial).This event was assessed as medically significant and was leading to disability.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (bilateral septic arthritis in the knees after infiltration with synvisc).At time of reporting, the outcome was not recovered /not resolved for the event bilateral septic arthritis in the knees after infiltration with synvisc.

Event Description

Bilateral septic arthritis in the knees after infiltration with synvisc [septic arthritis].Case narrative: initial information was received on 25-feb-2022 from italy regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 38 years old male patient who experienced bilateral septic arthritis in the knees after infiltration with synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].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 (strength: 16 mg/2 ml, dosage, frequency, route, batch number, indication, expiration date: unknown).On 07-feb-2022 (latency: unknown), the patient developed bilateral septic arthritis in the knees after infiltration with synvisc (arthritis bacterial).This event was assessed as medically significant and was leading to disability.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (bilateral septic arthritis in the knees after infiltration with synvisc).At time of reporting, the outcome was not recovered / not resolved for the event bilateral septic arthritis in the knees after infiltration with synvisc.A product technical complaint (ptc) was initiated on 28-feb-2022 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available and the ptc stated that the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa 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 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 adverse events as stated in sop rdg-sop-000440 product event handling to determine if a capa is required.The final investigation was completed on 30-mar-2022 with summarized conclusion as no assessment possible.Additional information was received on 28-feb-2022 from quality department (other healthcare professional).Gptc number was added.Additional information was received on 30-mar-2022 from the quality department.Ptc results were added along with the strength.Text amended accordingly.

Event Description

Bilateral septic arthritis in the knees after infiltration with synvisc (right knee) [septic arthritis].Unable to walk (right knee) [unable to walk].Case narrative: initial information was received on 25-feb-2022 from italy regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves 38 years old male patient who had bilateral septic arthritis in the knees after infiltration with synvisc and unable to walk after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) in both knees.The patient's past medical history, vaccination(s) and family history were not provided.Infiltrations with synvisc 2 ml syringes were performed twice a year since 2019.Concomitant therapies/drugs were reported as none.The patient received covid 19 vaccinations, the latest was in (b)(6) 2021.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate (strength: 16 mg/2ml), 3 injections once a week bilaterally in knees (batch number: arsp003c, expiration date: 28-feb-2023) (route, indication: unknown).The adverse reaction began gradually after the administration on (b)(6) 2022 and manifested itself completely in the night between (b)(6) 2022.On the morning of (b)(6) 2022 patient was hospitalized as he was unable to walk (gait inability, required hospitalization, and required intervention) and had bilateral septic arthritis in the knees after infiltration with synvisc (arthritis bacterial, required hospitalization and intervention, caused disability).As implemented medical countermeasures, 2 broad spectrum antibiotics (not otherwise specified) and one anti-inflammatory (not otherwise specified) were administered several times a day for 21 days.Various checks were carried out: blood count, radiographs, nuclear magnetic resonance, and synovial fluid examination.However, reports were not available.At the time of this report on (b)(6) 2022, the therapies were continued and there had certainly been an improvement.Currently, the patient was in the rehabilitation phase of the knees and surgery was avoided.Action taken: not applicable for both the events.Corrective treatment: 2 broad spectrum antibiotics (not otherwise specified) and one anti-inflammatory (not otherwise specified) for both the events.At time of reporting, the outcome was recovering for both the events.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc with global ptc number: (b)(4), batch number: arsp003c, expiration date: 28-feb-2023.The production and quality control documentation for lot number arsp003c expiration date (2023-02) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsp003c no capa is required.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.As of (b)(6) 2022 there are (b)(4) complaints on file for lot number arsp003 and all related sublots.(b)(4) complaints are on file for lot number arsp003: (4) adverse event reports, (1) leakage and (1) broken syringe.(b)(4) complaints are on file for lot number arsp003b: (2) adverse event reports.(b)(4) complaint is on file for lot number arsp003c: (1) adverse event report.Sanofi will continue to monitor complaints determine if a capa is required.The final investigation was completed on 06-apr-2022 and the summarized conclusion was 'no investigation possible.' additional information was received on 28-feb-2022 from quality department (other healthcare professional).Gptc number was added.Additional information was received on 30-mar-2022 from the quality department.Ptc results were added along with the strength.Text amended accordingly.Additional information was received on 30-mar-2022 and 06-apr-2022 (both processed together) from a patient and quality department.Event added- unable to walk.Therapy details were added.Lab data was added.For event of arthritis bacterial- seriousness was updated, corrective treatment was added, and outcome was updated.Previously received investigation results for unknown batch number were removed and batch number was added to the case.Updated investigation results were added.Clinical course was updated.Text amended accordingly.

Event Description

Bilateral septic arthritis in the knees after infiltration with synvisc (right knee) [septic arthritis] ([discomfort in joints], [knee swelling]) unable to walk (right knee) [unable to walk] case narrative: initial information was received on 25-feb-2022 from italy regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves 38 years old male patient who had bilateral septic arthritis in the knees after infiltration with synvisc and unable to walk after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) in both knees the patient's past medical history, vaccination(s) and family history were not provided.Infiltrations with synvisc 2 ml syringes were performed twice a year since 2019.Concomitant therapies/drugs were reported as none.The patient received covid 19 vaccinations, the latest was in (b)(6) 2021.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate (strength: 16 mg/2ml), 3 injections once a week bilaterally in knees (batch number: arsp003c, expiration date: 28-feb-2023) (route, indication: unknown).The adverse reaction began gradually after the administration on (b)(6) 2022 and manifested itself completely in the night between (b)(6) 2022.On (b)(6) 2022, after unknown exact latency, the patient had still slight discomfort in the flexion of the knees that are not yet 100% deflated (joint swelling, musculoskeletal discomfort).On the morning of (b)(6) 2022 patient was hospitalized as he was unable to walk (gait inability, required hospitalization, and required intervention) and had bilateral septic arthritis in the knees after infiltration with synvisc (arthritis bacterial, required hospitalization and intervention, caused disability).As implemented medical countermeasures, 2 broad spectrum antibiotics (not otherwise specified) and one anti-inflammatory (not otherwise specified) were administered several times a day for 21 days.Various checks were carried out: blood count, radiographs, nuclear magnetic resonance, and synovial fluid examination.However, reports were not available.At the time of this report on (b)(6) 2022, the therapies were continued and there had certainly been an improvement.Currently, the patient was in the rehabilitation phase of the knees and surgery was avoided.Reportedly, when the previous infiltrations were made on (b)(6), no problems in particular, the patient had continued to do sports activities and all infiltrations had been carried out by a doctor.Always the usual technique was used with 1 syringe per knee, undiluted product.The patient was not never took any medicines after the infiltration, neither ice nor rest.During the 21 days of treatment, when patient was monitored, several times to verify the effectiveness of the therapy, which luckily went well, also carried out several blood tests to monitor the values and patient was definitely improving, walked, was doing physiotherapy by introducing exercise bikes and swimming, nothing more for then and still slight discomfort in the flexion of the knees that are not yet 100% deflated.Action taken: not applicable for both the events.Corrective treatment: 2 broad spectrum antibiotics (not otherwise specified) and one anti-inflammatory (not otherwise specified) for both the events.At time of reporting, the outcome was recovering for both the events.A product technical complaint (ptc) was initiated on 28-feb-2022 for synvisc with global ptc number: 100204580, batch number: arsp003c, expiration date: 28-feb-2023.The production and quality control documentation for lot number arsp003c expiration date (2023-02) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsp003c no capa is required.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.As of 31mar2022 there are (b)(4) complaints on file for lot number arsp003 and all related sublots.(b)(4) complaints are on file for lot number arsp003: (b)(4) adverse event reports, (b)(4) leakage and (b)(4) broken syringe.(b)(4) complaints are on file for lot number arsp003b: (b)(4) adverse event reports.(b)(4) complaint is on file for lot number arsp003c: (b)(4) adverse event report.Sanofi will continue to monitor complaints determine if a capa is required.The final investigation was completed on 06-apr-2022 and the summarized conclusion was 'no investigation possible.' additional information was received on 28-feb-2022 from quality department (other healthcare professional).Gptc number was added.Additional information was received on 30-mar-2022 from the quality department.Ptc results were added along with the strength.Text amended accordingly.Additional information was received on 30-mar-2022 and 06-apr-2022 (both processed together) from a patient and quality department.Event added- unable to walk.Therapy details were added.Lab data was added.For event of arthritis bacterial- seriousness was updated, corrective treatment was added, and outcome was updated.Previously received investigation results for unknown batch number were removed and batch number was added to the case.Updated investigation results were added.Clinical course was updated.Text amended accordingly.Additional information was received on 12-feb-2022 from the patient.Musculoskeletal discomfort and joint swelling added as symptoms of arthritis bacterial.Clinical course was updated.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: 13685182
• MDR Text Key: 291308636
• Report Number: 2246315-2022-00021
• 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,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/28/2023
• Device Lot Number: ARSP003C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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): Hospitalization; Other; Required Intervention; Disability
• Patient Sex: Male