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

Lot Number UNKNOWN

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

Patient Problems Muscle Weakness (1967); Arthralgia (2355); Movement Disorder (4412); Peripheral Edema (4578)

Event Type  Injury  

Event Description

Trouble getting out of the bed [mobility decreased].Muscle is just recovering [muscle disorder].Knees were swollen 4 times the size they are normally [injection site joint swelling].Swelling in his ankle [ankle swelling].Pain [injection site joint pain].It has disturbed his sleep [sleep disturbance].Major reaction after injection, he apparently can not tolerate synvisc, causing an allergic reaction [allergic reaction] ([itchy skin], [skin burning sensation], [wheals], [skin sensitisation]).Case narrative: initial information received from united states on 31-may-2023 regarding an unsolicited valid serious case received from a patient.This case is linked with case (b)(4) (multiple devices used in a single patient).This case involves 71 years old male patient who had trouble getting out of the bed, muscle is just recovering, knees were swollen 4 times the size they are normally, swelling in his ankle, pain, it has disturbed his sleep and major reaction after injection, he apparently cannot tolerate synvisc, causing an allergic reaction, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection (with an unknown strength, dose, frequency, route, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.The patient reported a major reaction after injection (hypersensitivity, onset date and latency: unknown) in both knees.He stated his knees were swollen 4 times the size they were normally (injection site joint swelling, onset date and latency: unknown).He had swelling in his ankle (joint swelling, onset date and latency: unknown) and his muscle was just recovering (muscle disorder, onset date and latency: unknown).He had to use a walker for ambulation.He said the nurse attributed the ankle swelling to standing.He reported pain (injection site joint pain, onset date and latency: unknown) and sensitivity to clothes, including pants, socks, and boots (skin sensitisation, onset date and latency: unknown).He stated it has disturbed his sleep (sleep disorder, onset date and latency: unknown) and he had trouble getting out of the bed (mobility decreased, onset date and latency: unknown).He stated he apparently could not tolerate synvisc, causing an allergic reaction (hypersensitivity, onset date and latency: unknown) which makes his skin itch (pruritus, onset date and latency: unknown) and feel like it is "on fire"(skin burning sensation, onset date and latency: unknown), and he had whelps on his skin (urticaria, onset date and latency: unknown).He said he regrets getting the injections and it has been hell.He had been to a gi (gastroenterologist) doctor for symptoms.He was scheduled for surgery (b)(6)2023 and has had ct (computerized tomography) with another scan scheduled prior to surgery.He was told he would have extensive hospital stay for monitoring post op(operation) and rehab(rehabilitation).He asked how often other people have side effects.He asked if the synvisc was like a cushion.He was seeing health-care professional today.He was taking otc (over the counter) pain medications.No lab data was provided.Action taken: not applicable for all events.Corrective treatment: use a walker for ambulation for event injection site joint swelling, joint swelling, muscle disorder and mobility decreased.Otc (over the counter) pain medications for injection site joint pain.It was not reported if the patient received a corrective treatment for rest of the events.At time of reporting, the outcome was recovering for the event muscle disorder and was unknown for rest all the events.Seriousness criteria: disability for injection site joint swelling, joint swelling, muscle disorder and mobility decreased.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 06-jun-2023: this case involves 71 years old male patient who had tia trouble getting out of the bed and muscle disorder, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].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 case will be re-evaluated post further update patient's underlying disease conditions, past drug history, personal and family history, the details of which will aid in comprehensive case assessment.

Event Description

Trouble getting out of the bed [mobility decreased] muscle is just recovering [muscle disorder] knees were swollen 4 times the size they are normally [injection site joint swelling] swelling in his ankle [ankle swelling] pain [injection site joint pain] it has disturbed his sleep [sleep disturbance] major reaction after injection, he apparently can not tolerate synvisc, causing an allergic reaction [allergic reaction] ([itchy skin], [skin burning sensation], [wheals], [skin sensitisation]) case narrative: initial information received from united states on (b)(6) 2023 regarding an unsolicited valid serious case received from a patient.This case is linked with case (b)(4) and (b)(4) (multiple devices used in a single patient) and (b)(4) (multiple devices suspect for same patient; left knee, retained case) this case involves 71 years old male patient who had trouble getting out of the bed, muscle is just recovering, knees were swollen 4 times the size they are normally, swelling in his ankle, pain, it has disturbed his sleep and major reaction after injection, he apparently cannot tolerate synvisc, causing an allergic reaction, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection in left knee (with an unknown strength, dose, frequency, route, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.The patient reported a major reaction after injection (hypersensitivity, onset date and latency: unknown) in both knees.He stated his knees were swollen 4 times the size they were normally (injection site joint swelling, onset date and latency: unknown).He had swelling in his ankle (joint swelling, onset date and latency: unknown) and his muscle was just recovering (muscle disorder, onset date and latency: unknown).He had to use a walker for ambulation.He said the nurse attributed the ankle swelling to standing.He reported pain (injection site joint pain, onset date and latency: unknown) and sensitivity to clothes, including pants, socks, and boots (skin sensitisation, onset date and latency: unknown).He stated it has disturbed his sleep (sleep disorder, onset date and latency: unknown) and he had trouble getting out of the bed (mobility decreased, onset date and latency: unknown).He stated he apparently could not tolerate synvisc, causing an allergic reaction (hypersensitivity, onset date and latency: unknown) which makes his skin itch (pruritus, onset date and latency: unknown) and feel like it is "on fire"(skin burning sensation, onset date and latency: unknown), and he had whelps on his skin (urticaria, onset date and latency: unknown).He said he regrets getting the injections and it has been hell.He had been to a gi (gastroenterologist) doctor for symptoms.He was scheduled for surgery (b)(6) 2023 and has had ct (computerized tomography) with another scan scheduled prior to surgery.He was told he would have extensive hospital stay for monitoring post op(operation) and rehab(rehabilitation).He asked how often other people have side effects.He asked if the synvisc was like a cushion.He was seeing health-care professional today.He was taking otc (over the counter) pain medications.No lab data was provided.Action taken: not applicable for all events.Corrective treatment: use a walker for ambulation for event injection site joint swelling, joint swelling, muscle disorder and mobility decreased.Otc (over the counter) pain medications for injection site joint pain.It was not reported if the patient received a corrective treatment for rest of the events.At time of reporting, the outcome was recovering for the event muscle disorder and was unknown for rest all the events.Seriousness criteria: disability for injection site joint swelling, joint swelling, muscle disorder and mobility decreased.Upon internal review on (b)(6) 2023, this case (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).All the information from the case (b)(4) has been merged in the case (b)(4).Case (b)(4) with csd of (b)(6) 2023, would be deleted.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2023: new follow-up information received does not change the previous case assessment.This case involves 71 years old male patient who had trouble getting out of the bed and muscle disorder, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].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 case will be re-evaluated post further update patient's underlying disease conditions, past drug history, personal and family history, the details of which will aid in comprehensive case assessment.

• 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: 17070153
• MDR Text Key: 316932976
• Report Number: 2246315-2023-00061
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• 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 Age: 71 YR
• Patient Sex: Male