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

Lot Number UNKNOWN

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

Patient Problems Loss of Range of Motion (2032); Ambulation Difficulties (2544); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 15-apr-2024: this case involves "an approximately" 57 year old female patient who was unable to walk without the aid of crutches and had a bad reaction to her injection, her knee blew up to the point that they had to drain, after treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect device cannot be denied for the occurrence of events, however patient underlying condition of osteoarthritis could be the cofounding factor.The case will be re-evaluated post further update on patient's past medical and drug history, family history, concomitant medications the details of which will aid in comprehensive case assessment.

Event Description

She was unable to walk without the aid of crutches [unable to walk] her knee blew up to the point that they had to drain it [arthrocentesis] had a bad reaction to her injection, her knee blew up to the point that they had to drain it [injection site joint swelling] her knee blew up to the point that they had to drain it [injection site joint effusion] case narrative: initial information was received on 09-apr-2024 regarding an unsolicited valid serious case received from a patient.This case is linked with case id (b)(6) (multiple device suspect used in same patient).This case involves "an approximately" 57 year old female patient who was unable to walk without the aid of crutches and had a bad reaction to her injection, her knee blew up to the point that they had to drain it, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor in (b)(6) 2023, the patient started received hylan g-f 20, sodium hyaluronate at a dose of 3 x 2ml via route intra-articular in right knee (strength: 16mg/2ml, frequency: unknown) for osteoarthritis.The patient mentioned that she had a bad reaction to her injection.Patient said that she has had synvisc injections twice a year for several years with zero problems, however the last two she has had a reaction.Last summer, on an unknown date in 2023 (latency: unknown) (unknown batch number and expiry date), her knee blew up to the point that they had to drain it (injection site joint swelling) (aspiration joint) (injection site joint effusion) and she was unable to walk without the aid of crutches (gait inability).At the time her physician just attributed it to her arthritis, that it might have been so inflamed and could have been a reaction to the injection.She was inquiring if it was possible that she had developed an allergy to the injections.Information on batch number and expiry date was requested.Action taken: unknown for all events: corrective treatment: crutches for gait inability, aspiration of joint for injection site joint swelling and injection site joint effusion at time of reporting, the outcome was not recovered for all events.Seriousness criteria: disability for gait inability and intervention required for rest of the events.

Manufacturer Narrative

Sanofi company comment for follow-up dated 09-apr-2024: this case involves "an approximately" 58 year old female patient who was unable to walk without the aid of crutches,not being able to straighten the knee and had a bad reaction to her injection, started filling up, knee blew up to the point that they had to drain it, after treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect device cannot be denied for the occurrence of events, however patient underlying condition of osteoarthritis could be the co founding factor.The case will be re-evaluated post further update on patient's past medical and drug history, family history, concomitant medications the details of which will aid in comprehensive case assessment.

Event Description

She was unable to walk without the aid of crutches [unable to walk] not being able to straighten the knee [joint range of motion decreased] her knee blew up to the point that they had to drain it/fluid and synvisc was removed from the knee [arthrocentesis] had a bad reaction to her injection, started filling up, knee blew up to the point that they had to drain it [injection site joint swelling] her knee blew up to the point that they had to drain it/it started filling up/fluid and synvisc was removed from the knee [injection site joint effusion].Case narrative: initial information was received on 09-apr-2024 regarding an unsolicited valid serious case received from a patient.This case is linked with case id (b)(4) (multiple device suspect used in same patient).This case involves "an approximately" 58 year old female patient who was unable to walk without the aid of crutches, not being able to straighten the knee, had a bad reaction to her injection, started filling up, knee blew up to the point that they had to drain it, her knee blew up to the point that they had to drain it/fluid and synvisc was removed from the knee and her knee blew up to the point that they had to drain it/it started filling up/fluid and synvisc was removed from the knee with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor.The patient had used synvisc every 6-months, since 2021, for osteoarthritis of the right knee for several years with zero problems.In (b)(6) 2023, the patient received first hylan g-f 20, sodium hyaluronate injection, liquid (solution) of 3 injection series at a dose of 2ml via route intra-articular in right knee (strength: 16mg/2ml, frequency: unknown) for osteoarthritis of right knee.The patient mentioned that she had a bad reaction to her injection.Last summer, on an unknown date in 2023 (latency: unknown) (unknown batch number and expiry date), her knee started filling up and blew up to the point that they had to drain it (injection site joint swelling) (aspiration joint) (injection site joint effusion), was not able to straighten the knee (joint range of motion decreased) and she was unable to walk without the aid of crutches (gait inability) after getting the initial injection of the 3-injection series.The subsequent synvisc injections were stopped and the fluid and synvisc was removed from the knee.The issue resolved in a month and the provider was thinking it was a one time event and was not due to the synvisc.The patient's physician just attributed it to her arthritis, that it might have been so inflamed and could have been a reaction to the injection.Patient wanted to know if one could develop an allergy to synvisc after being on synvisc for some time and what were the percentages of people experiencing a reaction in the knee after getting synvisc.There will be no information on batch number and expiry date as the product was no longer available.Action taken: drug withdrawn in (b)(6) 2023 for all events.Corrective treatment: crutches for gait inability, fluid and synvisc was removed/drained from the knee for injection site joint swelling and injection site joint effusion, not reported for joint range of motion decreased.At time of reporting, the outcome was recovered in 2023 for all events.Seriousness criteria: disability for gait inability and joint range of motion decreased; intervention required for rest of the events.A product technical complaint (ptc) was initiated on 09-apr-2024 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample of the ptc was not available and the ptc was in process.Additional information was received on 09-apr-2024 from quality department via other healthcare professional: ptc number and details were added.Event of joint range of motion decreased was added.As reported verbatim for injection site joint swelling, injection site joint effusion and aspiration joint was updated.Action taken with suspect was updated.Event outcome for all events was updated.Clinical course was updated and text was amended.

Event Description

She was unable to walk without the aid of crutches [unable to walk] not being able to straighten the knee [joint range of motion decreased] her knee blew up to the point that they had to drain it/fluid and synvisc was removed from the knee [arthrocentesis] had a bad reaction to her injection, started filling up, knee blew up to the point that they had to drain it [injection site joint swelling] her knee blew up to the point that they had to drain it/it started filling up/fluid and synvisc was removed from the knee [injection site joint effusion] case narrative: initial information was received on 09-apr-2024 regarding an unsolicited valid serious case received from a patient.This case is linked with case id (b)(6)(multiple device suspect used in same patient).This case involves "an approximately" 58 year old female patient who was unable to walk without the aid of crutches, not being able to straighten the knee, had a bad reaction to her injection, started filling up, knee blew up to the point that they had to drain it, her knee blew up to the point that they had to drain it/fluid and synvisc was removed from the knee and her knee blew up to the point that they had to drain it/it started filling up/fluid and synvisc was removed from the knee with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.It is unknown if the patient had any medical history.At the time of this event, the patient had ongoing arthritis.The patient had used synvisc every 6-months, since 2021, for osteoarthritis of the right knee for several years with zero problems (however the last two she has had a reaction).In jul-2023, the patient received first hylan g-f 20, sodium hyaluronate injection, liquid (solution) of 3 injection series at a dose of 2ml via route intra-articular in right knee (strength: 16mg/2ml, frequency: unknown) for osteoarthritis of right knee.The patient mentioned that she had a bad reaction to her injection.Last summer, on an unknown date in 2023 (latency: unknown) (unknown batch number and expiry date), her knee started filling up and blew up to the point that they had to drain it (injection site joint swelling) (aspiration joint) (injection site joint effusion), was not able to straighten the knee (joint range of motion decreased) and she was unable to walk without the aid of crutches (gait inability) after getting the initial injection of the 3-injection series.The subsequent synvisc injections were stopped and the fluid and synvisc was removed from the knee.The issue resolved in a month and the provider was thinking it was a one time event and was not due to the synvisc.The patient's physician just attributed it to her arthritis, that it might have been so inflamed and could have been a reaction to the injection.Patient wanted to know if one could develop an allergy to synvisc after being on synvisc for some time and what were the percentages of people experiencing a reaction in the knee after getting synvisc.Upon follow up on (b)(6) 2024, reported that she was now able to put some pressure on her knee there will be no information on batch number and expiry date as the product was no longer available.Action taken: drug withdrawn in jul-2023 for all events.Corrective treatment: crutches for gait inability, fluid and synvisc was removed/drained from the knee for injection site joint swelling and injection site joint effusion, not reported for joint range of motion decreased.At time of reporting, the outcome was recovered in 2023 for all events.Seriousness criteria: disability for gait inability and joint range of motion decreased; intervention required for rest of the events.A product technical complaint (ptc) was initiated on 09-apr-2024 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample of the ptc was not available.Ptc stated: 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.(em (b)(6) 2024) investigation (em (b)(6) 2024) 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.The final investigation was completed on 29-apr-2024 with summarized conclusion as no assessment possible.Additional information was received on 09-apr-2024 from quality department via other healthcare professional: ptc number and details were added.Event of joint range of motion decreased was added.As reported verbatim for injection site joint swelling, injection site joint effusion and aspiration joint was updated.Action taken with suspect was updated.Event outcome for all events was updated.Clinical course was updated and text was amended.Follow up information was received on 10-apr-2024.No significant information was received.Additional information was received on 29-apr-2024 from quality department via other healthcare professional: ptc results were added.Clinical course was updated and 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: 19117672
• MDR Text Key: 340293181
• Report Number: 2246315-2024-00025
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2024; 04/30/2024
• 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): Disability; Required Intervention
• Patient Sex: Female