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

Lot Number ARSP017B

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

Patient Problems Aspiration/Inhalation (1725); Injection Site Reaction (4562); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2022

Event Type  Injury  

Event Description

Knee acutely swelled up the next day and he was hospitalized [injection site joint swelling].Aspirated 90 cc of turbulent looking joint fluid from left knee [injection site joint effusion].Aspirated 90 cc of turbulent looking joint fluid from left knee [arthrocentesis].Case narrative: initial information received on (b)(6) 2022 regarding an unsolicited valid serious case received from other health professional from canada.This case involves a 66 years old male patient who experienced knee acutely swelled up the next day and he was hospitalized and 90 cc of turbulent looking joint fluid from left knee, while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patients past medical treatment included 6 series of synvisc injections, over the years.Patient preferred the 3 shot 2 cc type synvisc injections.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection in left knee (lot - arsp017b, expiry: september 2023) (dose, frequency, route, strength: unknown) for osteoarthritis.The patients knee acutely swelled up the next day and he was hospitalized (onset (b)(6) 2022 and latency: 1 day) (hospitalization and intervention required) (injection site joint swelling).Patients knee blew up incredibly over a period of 18 hours.The patient visited the hospital on (b)(6) 2022 and was seen by the doctor at 10:30 am (ante meridian), where the doctor aspirated 90 cc of turbulent looking joint fluid from left knee (injection site joint effusion and aspiration joint) (hospitalization and intervention required) (onset (b)(6)2022 and latency: 1 day).Culture was sent and was negative.Patient was told that this reaction was probably due a faulty product as the doctor has been using synvisc since decades and had never seen a reaction like this, this itself was some kind of a chemical reaction that caused this.Patient was told that he should not have synvisc one in the left knee again.Further, patient would be referred for further treatment and a follow up in 2 weeks to reexamine and possibly give patient a cortisone injection.Relevant laboratory test results included: aspiration joint - on (b)(6) 2022: 90 cc of turbulent looking fluid, culture sent and was negative.Action taken: not applicable for all events.Corrective treatment: not reported for all events.Outcome: unknown for all events.A product technical complaint was initiated and results were pending for the same.

Manufacturer Narrative

Sanofi company comment (b)(6) 2022.This case involves a 66 years old male patient who experienced knee acutely swelled up the next day and he was hospitalized, aspirated 90 cc of turbulent looking joint fluid from left knee, while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] in left knee, after a latency of 1 day.The patient was hospitalized due to this and 90 cc of fluid had to be removed from the causative knee.The causal role of suspect product in the occurrence of event can not be excluded based upon the reaction and the temporal gap.

Event Description

Knee acutely swelled up the next day/knee blew up incredibly over a period of 18 hours [injection site joint swelling] aspirated 90 cc of turbulent looking joint fluid from left knee [injection site joint effusion] aspirated 90 cc of turbulent looking joint fluid from left knee [arthrocentesis] case narrative: this case is linked to case 2022sa327908 (multiple devices).Initial information received on 29-jul-2022 regarding an unsolicited valid serious case from other health professional from canada.This case involves a 66 years old male patient whose knee acutely swelled up the next day/knee blew up incredibly over a period of 18 hours and 90 cc of turbulent looking joint fluid from left knee, while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patients past medical treatment included 6 series of synvisc injections, over the years.Patient preferred the 3 shot 2 cc type synvisc injections.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate (16 mg/2ml), intra-articular, lateral injection in left knee (lot - arsp017b, expiry: 30-sep-2023) (dose, frequency, strength: unknown) for osteoarthritis, grade iv.The patients knee acutely swelled up the next day (onset (b)(6) 2022 and latency: 1 day) (intervention required) (injection site joint swelling, severe).Patient's knee blew up incredibly over a period of 18 hours.The patient visited the hospital on (b)(6) 2022 and was seen by the doctor at 10:30 am (ante meridian), where the doctor aspirated 90 cc of turbulent looking joint fluid from left knee ((b)(6) 2022 and latency: 1 day).The patient was not admitted to hospital but attended in emergency only.Culture was sent and was negative.Patient was told that this reaction was probably due a faulty product as the doctor has been using synvisc since decades and had never seen a reaction like this, this itself was some kind of a chemical reaction that caused this.Patient was told that he should not have synvisc one in the left knee again.Further, patient would be referred for further treatment and a follow up in 2 weeks to reexamine and possibly give patient a cortisone injection.Reporting physician considered that synvisc contributed to the reported adverse events and the events were not related to patient's pre-existing condition.The adverse events did not result in any permanent effect.The physician did not consider this intervention as unexpected.The patient received antiinflammation and joint was aspirated (90cc) to manage the adverse events.All the events resolved as of (b)(6) 2022.The company suspect product was not inappropriately used as per local marketing authorization.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Relevant laboratory test results included: aspiration joint - on (b)(6) 2022: 90 cc of turbulent looking fluid, culture sent and was negative action taken: not applicable for all events.Corrective treatment: antiinflammation and joint aspiration (90 cc) for injection site joint swelling and injection site joint effusion outcome: recovered for all events.Reporter causality: related for all events.Product technical complaint (ptc) was initiated with global ptc number 100248530 on 29-jul-2022 for synvisc.Batch number: lot - arsp017b, expiry: 30-sep-2023 sample was not available ptc stated: the production and quality control documentation for lot number arsp017b expiration date (2023-09) 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 numberarsp017b 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 30aug2022 there are 6 complaints on file for lot number arsp017 and all related sublots.6 complaints are on file for lot number arsp017b: (5) adverse event reports and (1) syringe broken before use.Sanofi will continue to monitor complaints to determine if a capa is required.The final investigation was completed on 06-sep-2022 with summarized conclusion as no assessment possible.Additional information was received on 11-aug-2022 from a physician.Intensity, outcome, corrective treatment, seriousness was updated for all events.Indication was updated.Injection technique information was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 06-sep-2022 from other healthcare professional (from quality department).Gptc results were received and added.Text was amended accordingly.

Manufacturer Narrative

Sanofi company comment for follow up dated 11-aug-2022: follow up information received does not change prior case assessment.This case involves a 66 years old male patient whose knee acutely swelled up the next day, and got aspirated 90 cc of turbulent looking joint fluid from left knee, while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] in left knee, after a latency of 1 day.The causal role of suspect product in the occurrence of event cannot be excluded based upon the reaction and the temporal gap.However, further information regarding patient¿s medical history, past medications, concomitant medications, and other risk factors would aid in better case assessment.

Event Description

Knee acutely swelled up the next day/knee blew up incredibly over a period of 18 hours [injection site joint swelling] aspirated 90 cc of turbulent looking joint fluid from left knee [injection site joint effusion] aspirated 90 cc of turbulent looking joint fluid from left knee [arthrocentesis] case narrative: initial information received on 29-jul-2022 regarding an unsolicited valid serious case from other health professional from canada.This case involves a 66 years old male patient whose knee acutely swelled up the next day/knee blew up incredibly over a period of 18 hours and 90 cc of turbulent looking joint fluid from left knee, while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patients past medical treatment included 6 series of synvisc injections, over the years.Patient preferred the 3 shot 2 cc type synvisc injections.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate, intra-articular, lateral injection in left knee (lot - arsp017b, expiry: september 2023) (dose, frequency, strength: unknown) for osteoarthritis, grade iv.The patients knee acutely swelled up the next day (onset (b)(6) 2022 and latency: 1 day) (intervention required) (injection site joint swelling, severe).Patient's knee blew up incredibly over a period of 18 hours.The patient visited the hospital on (b)(6) 2022 and was seen by the doctor at 10:30 am (ante meridian), where the doctor aspirated 90 cc of turbulent looking joint fluid from left knee (injection site joint effusion and aspiration joint, severe) (intervention required) (onset (b)(6) 2022 and latency: 1 day).The patient was not admitted to hospital but attended in emergency only.Culture was sent and was negative.Patient was told that this reaction was probably due a faulty product as the doctor has been using synvisc since decades and had never seen a reaction like this, this itself was some kind of a chemical reaction that caused this.Patient was told that he should not have synvisc one in the left knee again.Further, patient would be referred for further treatment and a follow up in 2 weeks to reexamine and possibly give patient a cortisone injection.Reporting physician considered that synvisc contributed to the reported adverse events and the events were not related to patient's pre-existing condition.The adverse events did not result in any permanent effect.The physician did not consider this intervention as unexpected.The patient received antiinflammation and joint was aspirated (90cc) to manage the adverse events.All the events resolved as of 11-aug-2022.The company suspect product was not inappropriately used as per local marketing authorization.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Relevant laboratory test results included: aspiration joint - on (b)(6) 2022: 90 cc of turbulent looking fluid, culture sent and was negative.Action taken: not applicable for all events.Corrective treatment: antiinflammation and joint aspiration (90 cc) for injection site joint swelling and injection site joint effusion outcome: recovered for all events.Reporter causality: related for all events a product technical complaint was initiated and results were pending for the same.Additional information was received on 11-aug-2022 from a physician.Intensity, outcome, corrective treatment, seriousness was updated for all events.Indication was updated.Injection technique information was added.Clinical course was updated.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 15195899
• MDR Text Key: 297569480
• Report Number: 2246315-2022-00093
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Lot Number: ARSP017B
• 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): Required Intervention; Hospitalization
• Patient Sex: Male