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); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 15-apr-2024: this case involves a 58 years old female patient who has not been able to walk or bend her, she was immobile, unable to bend the knee or put pressure on it, huge swelling knee and throbbing pain/started to feel some pain in the evening 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.However, further information of post injection routine, injection technique, past and concomitant medication, any family history would aid in better case assessment.

Event Description

She was immobile [immobile].Unable to bend the knee [joint range of motion decreased].Unable to put pressure on it [weight bearing difficulty].Has not been able to walk or bend her [unable to walk].Huge swelling (right knee) [injection site joint swelling].Throbbing pain/started to feel some pain in the evening [injection site joint pain].Case narrative: initial information received on 09-apr-2024 regarding an unsolicited valid serious case received from a patient.This case is linked with case (b)(4) (multiple device suspect used in same patient).This case involves a 58 years old female patient who has not been able to walk or bend her, she was immobile, unable to bend the knee or put pressure on it, huge swelling knee and throbbing pain/started to feel some pain in the evening with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.The patient had synvisc injections twice a year for several years with zero problems, however with the last injection ((b)(6) 2023) she had a reaction.On (b)(6) 2024 (around 5 p.M), patient started received hylan g-f 20, sodium hyaluronate injection at a dose of 3 x 2ml in right knee (strength: 16mg/2ml, frequency, route: unknown) for osteoarthritis.Reportedly, she had a bad reaction to her injection.On (b)(6) 2024, in the evening on same day, the patient started to feel some pain (injection site joint pain).Since (b)(6) 2024 (latency: same day or 1 day), the patient had not been able to walk or bend her knee for five days (gait inability) (joint range of motion decreased), had huge swelling (injection site joint swelling), throbbing pain, and unable to put pressure on it (weight bearing difficulty).On (b)(6) 2024 (next day) (latency: 1 day), the patient was immobile (with unknown batch number and expiry date for all the events).So, the patient had been using crutches.She was now able to put some pressure on her knee.Action taken: unknown for all the events.Corrective treatment: crutches for immobile, gait inability, joint range of motion decreased and weight bearing difficulty; not reported for other events.Outcome: recovering for weight bearing difficulty and not recovered for all other events.Seriousness criteria: medically significant and disability for immobile; disability for gait inability, joint range of motion decreased and weight bearing difficulty.

Manufacturer Narrative

Sanofi company comment for follow-up dated 09-apr-2024: this case involves a 58 years old female patient who was immobile, unable to bend the knee/not being able to straighten the knee, unable to put pressure on it, has not been able to walk/unable to walk on the right knee, 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 ignored.However, further information of post injection routine, injection technique, past and concomitant medication, any family history, medical history would aid in better case assessment.

Event Description

She was immobile [immobile] unable to bend the knee/not being able to straighten the knee [joint range of motion decreased] unable to put pressure on it [weight bearing difficulty] has not been able to walk/unable to walk on the right knee [unable to walk] huge swelling (right knee)/right knee blew up [injection site joint swelling] throbbing pain/started to feel some pain in the evening [injection site joint pain] 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 (b)(4) (multiple device suspect used in same patient).This case involves 58 years old female patient who was immobile, unable to bend the knee/not being able to straighten the knee, unable to put pressure on it, has not been able to walk/unable to walk on the right knee, huge swelling (right knee)/right knee blew up and throbbing pain/started to feel some pain in the evening, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.The patient had synvisc injections every 6-months, since 2021, for osteoarthritis of the right knee with zero problems, however with the last injection (in (b)(6)2023) she had a reaction.On (b)(6) 2024 (around 5 p.M), patient received first hylan g-f 20, sodium hyaluronate injection, liquid (solution) series at a dose of 2ml in right knee via route intra-articular (strength: 16mg/2ml, frequency: unknown) for osteoarthritis of right knee.The hcp (health care professional) tried this again thinking it was probably her arthritis that was inflamed last time in (b)(6) 2023.Reportedly, she had a bad reaction to her injection.On (b)(6) 2024, in the evening on same day, the patient started to feel some pain (injection site joint pain).Since 04 or (b)(6) 2024 (latency: same day or 1 day), the patient had not been able to walk or bend her knee for five days (gait inability) (joint range of motion decreased), had huge swelling, (right knee blew up) (injection site joint swelling), throbbing pain, and unable to put pressure on it (weight bearing difficulty).On (b)(6) 2024 (next day) (latency: 1 day), the patient was immobile (with unknown batch number and expiry date for all the events).So, the patient had been using crutches.She was now able to put some pressure on her knee.The treatment so far was stopping the synvisc series and bed rest.The provider was thinking it might be the condition of the patient's knee but did not known yet.The 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 would be no information on batch number and expiry date for this case as the product was no longer available.Action taken: drug withdrawn for all the events corrective treatment: crutches for immobile, gait inability, joint range of motion decreased and weight bearing difficulty; not reported for other events.Outcome: recovering for weight bearing difficulty and not recovered for all other events seriousness criteria: medically significant and disability for immobile; disability for gait inability, joint range of motion decreased and weight bearing difficulty.A product technical complaint (ptc) was initiated on 09-apr-2024 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 along with a live follow-up dated 09-apr-2024 from patient was received, both processed together with date 09-apr-2024: ptc number and details were added.As reported verbatim for joint range of motion decreased, gait inability, was updated.Route was added for suspect.Action taken with suspect was updated.Clinical course was updated and text was amended.

Event Description

She was immobile [immobile].Unable to bend the knee/not being able to straighten the knee [joint range of motion decreased].Unable to put pressure on it [weight bearing difficulty].Has not been able to walk/unable to walk on the right knee [unable to walk].Huge swelling (right knee)/right knee blew up [injection site joint swelling].Throbbing pain/started to feel some pain in the evening [injection site joint pain].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 (b)(4) (multiple device suspect used in same patient).This case involves 58 years old female patient who was immobile, unable to bend the knee/not being able to straighten the knee, unable to put pressure on it, has not been able to walk/unable to walk on the right knee, huge swelling (right knee)/right knee blew up and throbbing pain/started to feel some pain in the evening, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.The patient had synvisc injections every 6-months, since 2021, for osteoarthritis of the right knee with zero problems, however with the last injection (in (b)(6) 2023) she had a reaction.On (b)(6) 2024 (around 5 p.M), patient received first hylan g-f 20, sodium hyaluronate injection, liquid (solution) series at a dose of 2ml in right knee via route intra-articular (strength: 16mg/2ml, frequency: unknown) for osteoarthritis of right knee.The hcp (health care professional) tried this again thinking it was probably her arthritis that was inflamed last time in (b)(6) 2023.Reportedly, she had a bad reaction to her injection.On (b)(6) 2024, in the evening on same day, the patient started to feel some pain (injection site joint pain).Since (b)(6) 2024 (latency: same day or 1 day), the patient had not been able to walk or bend her knee for five days (gait inability) (joint range of motion decreased), had huge swelling, (right knee blew up) (injection site joint swelling), throbbing pain, and unable to put pressure on it (weight bearing difficulty).On (b)(6) 2024 (next day) (latency: 1 day), the patient was immobile (with unknown batch number and expiry date for all the events).So, the patient had been using crutches.She was now able to put some pressure on her knee.The treatment so far was stopping the synvisc series and bed rest.The provider was thinking it might be the condition of the patient's knee but did not known yet.The 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 would be no information on batch number and expiry date for this case as the product was no longer available.Action taken: drug withdrawn for all the events.Corrective treatment: crutches for immobile, gait inability, joint range of motion decreased and weight bearing difficulty; not reported for other events.Outcome: recovering for weight bearing difficulty and not recovered for all other events.Seriousness criteria: medically significant and disability for immobile; disability for gait inability, joint range of motion decreased and weight bearing difficulty.A product technical complaint (ptc) was initiated on 09-apr-2024 synvisc (lot/batch number: unknown) with global ptc number: 100417088.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.Investigation 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 as per (b)(4) (abbreviation meaning not known, request for clarification not possible).Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis as per (b)(4) 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 along with a live follow-up dated (b)(6) 2024 from patient was received, both processed together with date (b)(6) 2024: ptc number and details were added.As reported verbatim for joint range of motion decreased, gait inability, was updated.Route was added for suspect.Action taken with suspect was updated.Clinical course was updated and text was amended.Additional information was received on 29-apr-2024 from quality department via other healthcare professional.Ptc details and end date was added.Clinical course was updated and text was amended.

• 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: 19116966
• MDR Text Key: 340287460
• Report Number: 2246315-2024-00024
• 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; Other
• Patient Sex: Female