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

Lot Number 8RSP003B

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

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

Event Date 01/01/2020

Event Type  Injury  

Event Description

Upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking my usual 4-5 miles/day, yoga poses (even simple ones child's pose), and squatting down to pick something up.[activities of daily living impaired] upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking, yoga poses, squatting down to pick something up, limping and barely able to take the dog for a walk around the block [muscle stiffness] walk put weight on my legs, both knees were very swollen and painful [difficulty in standing] could barely stand up.Walk put weight on legs, both knees were very swollen and painful [weight bearing difficulty] uncomfortable to sleep the night.[sleep disturbance] noticed a minor rash on knees, shins and arms, rash was slightly itchy through became more itchy [itchy rash] knees began to ache.Especially the left knee/ knee tenderness/ both knees were very swollen and painful [aching (l) knee] aspirated both knees [effusion (l) knee] the fluid analysis came back with inflammatory cells and no bacteria in either knee [joint inflammation] ([knee swelling]) case narrative: initial information received on 22-mar-2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to case (b)(6).(same patient, right knee.) this case involves adult patient who experienced upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up, could barely stand up, walk put weight on legs, both knees were very swollen, noticed a minor rash on knees, shins.And arms, rash was slightly itchy through became more itchy, knees began to ache, especially the left knee/ knee tenderness/both knees were very swollen and painful and met doctor who aspirated both knees, the fluid analysis came back with inflammatory cells and no bacteria in either knee and uncomfortable to sleep the night while he/she was treated 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 the unknown date of 2020, the patient started using hylan g-f 20, sodium hyaluronate injection (indication, frequency: unknown) (lot - 8rsp003b) at the dose of 2 ml via intra-articular route in left knee.On the same day starting of hylan g-f 20, sodium hyaluronate, patient experience that upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up (loss of personal independence in daily activities) (disability) (musculoskeletal stiffness) (muscle tightness) (gait disturbance).On the same night, patient also reported that patient was uncomfortable to sleep the night (sleep disorder).Patient could barely stand up, walk put weight on legs, both knees were very swollen and painful (dysstasia) (weight bearing difficulty) (arthralgia) (joint swelling).Patient met doctor who met doctor who aspirated both knees, the fluid analysis came back with inflammatory cells and no bacteria in either knee (joint effusion) (arthritis).Patient also noticed that noticed a minor rash on knees, shins and arms, rash was slightly itchy through became more itchy (rash pruritic).It was also reported that there was minimal improvement in patient's ability to stand and walk.Doctor again aspirated knees again and iced them for several days afterwards and applied medicine twice a day for two weeks.Patient also increased curcumin dose, turmeric to 500 mg per day to help with inflammation.On the unknown date of 2021, patient was first time able to walk 3 miles on the flat surfaces with a limp.Patient's knee tenderness didn't completely went away.It was also reported that at that time patient was uncomfortable in getting out of car.Final diagnosis was upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up, could barely standup, walk put weight on legs, both knees were very swollen, noticed a minor rash on knees, shins and arms, rash was slightly itchy through became more itchy, knees began to ache, especially the left knee/ knee tenderness/both knees were very swollen and painful and met doctor who aspirated both knees, the fluid analysis came back with inflammatory cells and no bacteria in either knee and uncomfortable to sleep the night.Action taken: unknown for all the events.Corrective treatment: diphenhydramine hydrochloride (benadryl) for rash was slightly itchy; curcumin, ice for inflammation; not reported for rest all the events.Outcome: recovering for could barely stand up, walk put weight on legs, both knees were very swollen and painful (joint swelling) (dysstasia) (weight bearing difficulty), upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up (gait disturbance); unknown for rest all the events.Seriousness criteria: disability for upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up.A product technical compliant was initiated and results were pending for same.

Event Description

Upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking my usual 4-5 miles/day, yoga poses (even simple one¿s child's pose), and squatting down to pick something up.[activities of daily living impaired] upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking, yoga poses, squatting down to pick something up, limping and barely able to take the dog for a walk around the block [muscle stiffness] upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking, yoga poses, squatting down to pick something up, limping and barely able to take the dog for a walk around the block [muscle tightness] could barely standup.Walk put weight on my legs, both knees were very swollen and painful [difficulty in standing] could barely standup.Walk put weight on legs, both knees were very swollen and painful [weight bearing difficulty] upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking, yoga poses, squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up [walking difficulty] uncomfortable to sleep the night [sleep disturbance] noticed a minor rash on knees, shins.And arms, rash was slightly itchy through became more itchy [itchy rash] knees began to ache.Especially the left knee/ knee tenderness/ both knees were very swollen and painful [aching (l) knee] aspirated both knees [effusion (l) knee] the fluid analysis came back with inflammatory cells and no bacteria in either knee [joint inflammation] ([knee swelling]).Case narrative: initial information received on (b)(6) 2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to case (b)(4).(same patient, right knee).This case involves adult patient who experienced upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up, could barely standup, walk put weight on legs, both knees were very swollen, noticed a minor rash on knees, shins.And arms, rash was slightly itchy through became more itchy, knees began to ache, especially the left knee/ knee tenderness/both knees were very swollen and painful and met doctor who aspirated both knees, the fluid analysis came back with inflammatory cells and no bacteria in either knee and uncomfortable to sleep the night while he/she was treated 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 the unknown date of 2020, the patient started using hylan g-f 20, sodium hyaluronate injection (indication, frequency: unknown) (lot - 8rsp003b, expiry: jan-2021) at the dose of 2 ml via intra-articular route in left knee.On the same day starting of hylan g-f 20, sodium hyaluronate, patient experience that upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up (loss of personal independence in daily activities) (disability) (musculoskeletal stiffness) (muscle tightness) (gait disturbance).On the same night, patient also reported that patient was uncomfortable to sleep the night (sleep disorder).Patient could barely standup, walk put weight on legs, both knees were very swollen and painful (dysstasia) (weight bearing difficulty) (arthralgia) (joint swelling).Patient met doctor who met doctor who aspirated both knees, the fluid analysis came back with inflammatory cells and no bacteria in either knee (joint effusion) (arthritis).Patient also noticed that noticed a minor rash on knees, shins and arms, rash was slightly itchy through became more itchy (rash pruritic).It was also reported that there was minimal improvement in patient's ability to stand and walk.Doctor again aspirated knees again and iced them for several days afterwards and applied medicine twice a day for two weeks.Patient also increased curcumin dose, turmeric to 500 mg per day to help with inflammation.On the unknown date of 2021, patient was first time able to walk 3 miles on the flat surfaces with a limp.Patient's knee tenderness didn't completely went away.It was also reported that at that time patient was uncomfortable in getting out of car.Final diagnosis was upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up, could barely standup, walk put weight on legs, both knees were very swollen, noticed a minor rash on knees, shins and arms, rash was slightly itchy through became more itchy, knees began to ache, especially the left knee/ knee tenderness/both knees were very swollen and painful and met doctor who aspirated both knees, the fluid analysis came back with inflammatory cells and no bacteria in either knee and uncomfortable to sleep the night.Action taken: unknown for all the events.Corrective treatment: diphenhydramine hydrochloride (benadryl) for rash was slightly itchy; curcumin, ice for inflammation; not reported for rest all the events.Outcome: recovering for could barely standup, walk put weight on legs, both knees were very swollen and painful (joint swelling) (dysstasia) (weight bearing difficulty), upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up (gait disturbance); unknown for rest all the events.Seriousness criteria: disability for upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking usual 4-5 miles/day, yoga poses (even simple one's child's pose), and squatting down to pick something up, limping and barely able to take the dog for a walk around the block/couldn't go up.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc, batch number: 8rsp003b with global ptc number: (b)(4).The production and quality control documentation for lot 8rsp003b expiration date (2021-01) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot 8rsp003b no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of (b)(6) 2021 there were 5 complaints on file for lot 8rsp003 and all related sublots.5 complaints were on file for lot 8rsp003b: (5) adverse event reports.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation was completed on (b)(6) 2021.Follow up information was received on (b)(6) 2021 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on (b)(6) 2021 from other healthcare professional.Ptc results were added.Expiry date was added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11574895
• MDR Text Key: 255428570
• Report Number: 2246315-2021-00086
• 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
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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: No Information
• Device Expiration Date: 01/01/2021
• Device Lot Number: 8RSP003B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability