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 Diarrhea (1811); Pain (1994); Vomiting (2144); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Right leg was now twice the size of the other leg [swelling of legs], right leg being now deformed [leg deformity nos], terrible pain in the back [back pain], vomiting [vomiting], diarrhea [diarrhea], elevated blood sugar [blood sugar increased], hemoglobin a1c was elevated [hemoglobin a1c increased], terrible pain in right knee [aching (r) knee].Case narrative: initial information received on 15-jan-2020 from united states regarding an unsolicited valid serious case received from a consumer.This case involves a (b)(6) years old female patient who experienced right leg was now twice the size of the other leg, terrible pain in the back, vomiting, diarrhea, elevated blood sugar, right leg being now deformed, hemoglobin a1c was elevated and terrible pain in right knee, while she using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included broken right patella.At the time of the event, the patient had ongoing arthritis and osteoarthritis.The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On an unknown date in 2019, in the summer or fall, the patient started treatment with three series injection of hylan g-f 20, sodium hyaluronate at dosage 1 df, frequency 3x via intra-articular route (batch, indication: unknown) in her right knee by a doctor.After the first injection, patient experienced pain and she asked her doctor if it was normal with hylan g-f 20, sodium hyaluronate.The patient's doctor proceeded with the therapy and administered the second and third injections a week later.Patient reported she had received hylan g-f 20, sodium hyaluronate as her right knee was not strong enough after recovering from a broken right patella.On an unknown date in 2019 after the injection, patient experienced right leg was now twice the size of the other leg (latency: unknown) and she had to use a walker and underwent physical therapy.This event was assessed as serious and resulted in disability.Patients reported she was unable to wear her socks or pants and had to get new pants due to the increased leg size.The same time, patient also experienced terrible pain in the back (latency: unknown), vomiting (latency: unknown), diarrhea (latency: unknown), elevated blood sugar (latency: unknown), right leg being now deformed (latency: unknown) (disability), hemoglobin a1c was elevated (latency: unknown) and terrible pain in right knee (latency: unknown).Patient was advised by her prescriber that it was not normal.Patients healthcare provider believed patients events were due to reaction to hylan g-f 20, sodium hyaluronate and she was advised to not get hylan g-f 20, sodium hyaluronate again.Patient consulted three other providers as well and was told that there was nothing that could be done.As a corrective treatment for her pain, patient was given 20 pain pills.As a corrective treatment for her vomiting and diarrhea, patient was given unspecified pills.Patient reported her blood sugar was elevated to 200 and 350 from her normal 100 to 110, after the injection.Further, her hemoglobin a1c was also elevated to 9.2.Patient mentioned she had to lay flat for two months after the injection and her primary care reported that there was nothing they could do to help the right leg.Action taken: no action taken.Corrective treatment: walker and physical therapy for right leg was now twice the size of the other leg and right leg being now deformed; pills for vomiting, diarrhea; 20 pain pills and physical therapy for terrible pain in the back and terrible pain in right knee; not reported for rest.Outcome: not recovered/not resolved for all events.A product technical complaint was initiated and results were pending for the same.

Event Description

Right leg was now twice the size of the other leg [swelling of legs] right leg being now deformed [leg deformity nos] terrible pain in the back [back pain] vomiting [vomiting] diarrhea [diarrhea] elevated blood sugar [blood sugar increased] hemoglobin a1c was elevated [hemoglobin a1c increased] terrible pain in right knee [aching (r) knee] case narrative: initial information received on 15-jan-2020 from united states regarding an unsolicited valid serious case received from a consumer.This case involves an 83 years old female patient who experienced right leg was now twice the size of the other leg, terrible pain in the back, vomiting, diarrhea, elevated blood sugar, right leg being now deformed, hemoglobin a1c was elevated and terrible pain in right knee, while she using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included broken right patella.At the time of the event, the patient had ongoing arthritis and osteoarthritis.The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On an unknown date in 2019, in the summer or fall, the patient started treatment with three series injection of hylan g-f 20, sodium hyaluronate (dosage strength 16 mg/2ml) at dosage 1 df, frequency 3x via intra-articular route (batch, indication: unknown) in her right knee by a doctor.After the first injection, patient experienced pain and she asked her doctor if it was normal with hylan g-f 20, sodium hyaluronate.The patient's doctor proceeded with the therapy and administered the second and third injections a week later.Patient reported she had received hylan g-f 20, sodium hyaluronate as her right knee was not strong enough after recovering from a broken right patella.On an unknown date in 2019 after the injection, patient experienced right leg was now twice the size of the other leg (latency: unknown) and she had to use a walker and underwent physical therapy.This event was assessed as serious and resulted in disability.Patients reported she was unable to wear her socks or pants and had to get new pants due to the increased leg size.The same time, patient also experienced terrible pain in the back (latency: unknown), vomiting (latency: unknown), diarrhea (latency: unknown), elevated blood sugar (latency: unknown), right leg being now deformed (latency: unknown) (disability), hemoglobin a1c was elevated (latency: unknown) and terrible pain in right knee (latency: unknown).Patient was advised by her prescriber that it was not normal.Patients healthcare provider believed patients events were due to reaction to hylan g-f 20, sodium hyaluronate and she was advised to not get hylan g-f 20, sodium hyaluronate again.Patient consulted three other providers as well and was told that there was nothing that could be done.As a corrective treatment for her pain, patient was given 20 pain pills.As a corrective treatment for her vomiting and diarrhea, patient was given unspecified pills.Patient reported her blood sugar was elevated to 200 and 350 from her normal 100 to 110, after the injection.Further, her hemoglobin a1c was also elevated to 9.2.Patient mentioned she had to lay flat for two months after the injection and her primary care reported that there was nothing they could do to help the right leg.Action taken: no action taken for all events corrective treatment: walker and physical therapy for right leg was now twice the size of the other leg and right leg being now deformed; pills for vomiting, diarrhea; 20 pain pills and physical therapy for terrible pain in the back and terrible pain in right knee; not reported for rest of the events outcome: not recovered/not resolved for all events a product technical complaint (ptc) was initiated on 16-jan-2020 for synvisc.Batch number: unknown; global ptc number: 100016725.The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation complete date: 23-feb-2020 follow up information received on 16-jan-2020.No new information received.Additional information was received on 23-feb-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 9636114
• MDR Text Key: 190513124
• Report Number: 2246315-2020-00019
• 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: 02/27/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability