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 Problem Movement Disorder (4412)

Event Date 07/15/2022

Event Type  Injury  

Event Description

Stopped her to walk or to move or bend legs/couldn't move her knees/has to use crotches for now to walk [difficulty in walking] stopped her to walk or to move or bend legs/couldn't move her knees [injection site joint movement impairment] stopped her to walk or to move or bend legs [injected limb mobility decreased] heavy inflation around both knees [injection site joint swelling] terrible pain in both knees/crazy pain/huge pain [injection site joint pain] case narrative: initial information received on (b)(6) 2022 regarding an unsolicited valid serious case received from a consumer from (b)(6).This case is linked to (b)(4) (same patient, right knee).This case involves a 45 years old female patient who had stopped her to walk or to move or bend legs/couldn't move her knees/has to use crotches for now to walk, heavy inflation around both knees and terrible pain in both knees/crazy pain/huge pain while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] which was received in left knee.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient said she got 2 treatments of synvisc-one before in (b)(6) 2021 and also one in (b)(6) 2021, with no problem, and it was a different doctor who injected it before.She never had an allergic reaction to any medications on (b)(6) 2022, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection in left knee (with an unknown batch number, expiry date, dose, frequency, strength, route, and indication).Information on batch number was requested.Patient had synvisc-one injection on her both knees on (b)(6) 2022.The doctor injected under ultrasound supervision and froze the injection spot in advance.It was not the first-time that she had an injection she had it twice before without any problem.As per patient, she had asked the most recent doctor who injected her, if there was any extra fluid prior to her injection, and she was told that there was none, so the procedure went accordingly under ultrasound.She said the first day of the injection, there was no problem and the morning after, on (b)(6) 2022, after latency of 1 day, when she woke up, she faced terrible pain in both knees (injection site joint pain) with heavy inflation around both knees (injection site joint swelling) (injection site joint effusion, medically significant) that stopped her to walk (gait disturbance) (disability) or to move or bend her legs (injected limb mobility decreased).She could not move her knees (injection site joint movement impairment), she took pain killers and also tried to use ice, but both knees, especially the left knee was worst, but then 12 hours after, the right knee started to feel the same.The doctor who had injected her was advised and notified, but the doctor and his clinic told the patient that they could not do anything and only asked the patient to go to the hospital.After 2 days of pain, she went to the emergency and spent a whole day in the hospital, they concluded that it was a reaction to the synvisc injection.She had huge pain that forced her to use medication regularly (advil, naproxen, hydromorphone).Patient had also confirmed that the hospital hcps told her that there was no infection, as they did blood test, and they also took the fluid sample to check and that she was being followed by the hcps in the hospital.The patient asked how it could be a reaction although she did not have any problem before.Also, she asked if it could be the wrong process of injection from the doctor.She asked that how she could be sure that it was only a reaction although she never had an allergic reaction to any medications before.Patient said that presently, the crazy pain was gone, but she had to use crotches for now to walk.Patient added that the hospital hcps were optimistic of her recovery.She would go back for another checkup next week at the hospital.For now, her right knee felt better, left knee was still worse, but both have similar inflation.Mis thought that the patient meant inflammation, but patient kept on saying inflation.Patient did not have the lot number of the 2 synvisc-one injections, as the boxes were left at the clinic.Patient wished to be contacted.Patient had given the coordinates of the doctor who injected her this time and consented to be contacted.Action taken: not applicable for all the events corrective treatment: ibuprofen (advil); naproxen; and hydromorphone for injection site joint pain and injection site joint swelling; crutches for gait disturbance at time of reporting, the outcome was recovering/resolving for all the events a product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment (b)(6) 2022.This case concerns a 45 years old female patient who faced terrible pain in her both knees with heavy inflation around both knees that stopped her to walk or to move or bend her legs while being treated with hylan g-f 20, sodium hyaluronate [synvisc one], which occurred after 1 day of suspect administration and resulted in use of crotches.The temporal gap and nature of event was suggestive to have occurred due to the suspect product and causal role of the suspect could not denied.Case will be re-evaluated post further update on the patients underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Manufacturer Narrative

Sanofi company comment 03-sep-2022.Follow up information received did not change the previous assessment of the case.This case concerns a 45 years old female patient who faced terrible pain in her both knees with heavy inflation around both knees that stopped her to walk or to move or bend her legs while being treated with hylan g-f 20, sodium hyaluronate [synvisc one], which occurred after 1 day of suspect administration and resulted in use of crotches.The temporal gap and nature of event was suggestive to have occurred due to the suspect product and causal role of the suspect could not denied.Case will be re-evaluated post further update on the patients underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Stopped her to walk or to move or bend legs/couldn't move her knees/has to use crotches for now to walk [difficulty in walking] stopped her to walk or to move or bend legs/couldn't move her knees [injection site joint movement impairment] stopped her to walk or to move or bend legs [injected limb mobility decreased] heavy inflation around both knees [injection site joint swelling] terrible pain in both knees/crazy pain/huge pain [injection site joint pain].Case narrative: initial information received on 20-jul-2022 regarding an unsolicited valid serious case received from a consumer from canada.This case is linked to (b)(4) (same patient, right knee).This case involves a 45 years old female patient who had stopped her to walk or to move or bend legs/couldn't move her knees/has to use crotches for now to walk, heavy inflation around both knees and terrible pain in both knees/crazy pain/huge pain while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] which was received in left knee.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient said she got 2 treatments of synvisc-one before in (b)(6) 2021 and also one in (b)(6) 2021, with no problem, and it was a different doctor who injected it before.She never had an allergic reaction to any medications.On (b)(6) 2022, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection in left knee (with an unknown batch number, expiry date, dose, frequency, strength, route, and indication).Information on batch number was requested.Patient had synvisc-one injection on her both knees on (b)(6) 2022.The doctor injected under ultrasound supervision and froze the injection spot in advance.It was not the first-time that she had an injection she had it twice before without any problem.As per patient, she had asked the most recent doctor who injected her, if there was any extra fluid prior to her injection, and she was told that there was none, so the procedure went accordingly under ultrasound.She said the first day of the injection, there was no problem and the morning after, on (b)(6) 2022, after latency of 1 day, when she woke up, she faced terrible pain in both knees (injection site joint pain) with heavy inflation around both knees (injection site joint swelling) (injection site joint effusion, medically significant) that stopped her to walk (gait disturbance) (disability) or to move or bend her legs (injected limb mobility decreased).She could not move her knees (injection site joint movement impairment), she took pain killers and also tried to use ice, but both knees, especially the left knee was worst, but then 12 hours after, the right knee started to feel the same.The doctor who had injected her was advised and notified, but the doctor and his clinic told the patient that they could not do anything and only asked the patient to go to the hospital.After 2 days of pain, she went to the emergency and spent a whole day in the hospital, they concluded that it was a reaction to the synvisc injection.She had huge pain that forced her to use medication regularly (advil, naproxen, hydromorphone).Patient had also confirmed that the hospital hcps told her that there was no infection, as they did blood test, and they also took the fluid sample to check and that she was being followed by the hcps in the hospital.The patient asked how it could be a reaction although she did not have any problem before.Also, she asked if it could be the wrong process of injection from the doctor.She asked that how she could be sure that it was only a reaction although she never had an allergic reaction to any medications before.Patient said that presently, the crazy pain was gone, but she had to use crotches for now to walk.Patient added that the hospital hcps were optimistic of her recovery.She would go back for another checkup next week at the hospital.For now, her right knee felt better, left knee was still worse, but both have similar inflation.Mis thought that the patient meant inflammation, but patient kept on saying inflation.Patient did not have the lot number of the 2 synvisc-one injections, as the boxes were left at the clinic.Patient wished to be contacted.Patient had given the coordinates of the doctor who injected her this time and consented to be contacted.Action taken: not applicable for all the events.Corrective treatment: ibuprofen (advil); naproxen; and hydromorphone for injection site joint pain and injection site joint swelling; crutches for gait disturbance.At time of reporting, the outcome was recovering/resolving for all the events a ptc (product technical complaint) was initiated on 20-jul-2022 for synvisc one (with batch number: unknown) with global ptc number: (b)(4).The status of sample was not available and ptc stated the product lot number was not provided; a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review batch records for specification conformance prior to release.Any out of specification result was identified and mitigation through ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assess possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The review had not indicated any safety issue.The final investigation was completed: 03-sep-2022.Summarized conclusion for this case is no assessment possible.Additional information received on 03-sep-2022 from other health professional from quality department.Global ptc number and ptc results added.Text amended accordingly.

• 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: 15161742
• MDR Text Key: 297208867
• Report Number: 2246315-2022-00088
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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: 08/03/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/11/2022
• 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