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 Arthritis (1723); Unspecified Infection (1930); Inflammation (1932); Ambulation Difficulties (2544)

Event Date 01/01/2023

Event Type  Injury  

Event Description

This could be an infection (knee) [joint infection] ([injection site joint discomfort], [injection site joint pain], [condition aggravated], [injection site joint swelling], [injection site joint inflammation], [stiff knees]), difficulty getting up [difficulty in standing], difficulty getting up and walking [walking difficulty].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 to cases and (b)(6)(multiple devices used in a single patient).This case involves 57 years old female patient who had difficulty getting up and walking and this could be an infection (knee), while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included she took received synvisc-one a couple of years ago and had no issues.She added that she knew that there was a synvisc-one recall in 2017.She requests additional information regarding this.She asked if there was a current recall.Spoke per fda (food and drug administration) website in regard to additional details of the synvisc-one recall.Added that there was no information regarding a recall at this time and the exp date of the recalled lot expired in 2020.The patient's past medical history, and family history were not provided.On (b)(6) 2023, the patient received the third injection of synvisc (hylan g-f 20, sodium hyaluronate) series (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 developed a worsening of knee pain (injection site joint pain and condition aggravated), swelling (injection site joint swelling), inflammation (injection site joint inflammation), stiffness (joint stiffness), increased pressure of the knee (injection site joint discomfort), and difficulty getting up (dysstasia) and walking (gait disturbance).She had been treating this with ice, elevation, tylenol arthritis, and ibuprofen, however the symptoms were not resolving.The patient was now requiring a walker and had an application in for a scooter.The patient had been in touch with her health-care professional and has an appointment on (b)(6) 2023.She has spoken with the nurse last week and today.The patient was concerned that this could be an infection (arthritis infective).Action taken: not applicable for all events.Corrective treatment: ice, elevation, paracetamol (tylenol arthritis), ibuprofen for arthritis infective and its symptoms, requiring a walker and an application in for a scooter for dysstasia and gait disturbance.At time of reporting, the outcome was not recovered for all events.Seriousness criteria: medically significant for arthritis infective and its symptoms, disability for dysstasia and gait disturbance.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2023: this case involves a 57 years old female patient who had difficulty getting up and walking, this could be an infection (knee), while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].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 on patient's underlying disease conditions, past drug history, concurrent illnesses, personal and family history, the details of which will aid in comprehensive case assessment.

Event Description

Difficulty getting up [difficulty in standing].Difficulty getting up and walking [walking difficulty].This could be an infection (knee) [joint infection].Inflammation (knee) [injection site joint inflammation] ([injection site joint discomfort], [injection site joint pain], [condition aggravated], [stiff knees], [injection site joint swelling]).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 to cases and (b)(4) (multiple devices used in a single patient).This case involves 57 years old female patient who had difficulty getting up and walking and this could be an infection and inflammation (knee), while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included she took received synvisc-one a couple of years ago and had no issues.The patient's past medical history, and family history were not provided.On (b)(6) 2023, the patient received the third injection of synvisc (hylan g-f 20, sodium hyaluronate) series of strength: 16 mg/2 ml (with an unknown dose, frequency, route, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.The patient developed a worsening of knee pain (injection site joint pain and condition aggravated), swelling (injection site joint swelling), inflammation (injection site joint inflammation), stiffness (joint stiffness), increased pressure of the knee (injection site joint discomfort), and difficulty getting up (dysstasia) and walking (gait disturbance).She had been treating this with ice, elevation, tylenol arthritis, and ibuprofen, however the symptoms were not resolving.The patient was now requiring a walker and had an application in for a scooter.The patient had been in touch with her health-care professional and has an appointment on (b)(6) 2023.She has spoken with the nurse last week and today.The patient was concerned that this could be an infection (arthritis infective).She added that she knew that there was a synvisc-one recall in 2017.She requests additional information regarding this.She asked if there was a current recall.Spoke per fda (food and drug administration) website in regard to additional details of the synvisc-one recall.Added that there was no information regarding a recall at this time and the exp date of the recalled lot expired in 2020 action taken: not applicable for all events.Corrective treatment: ice, elevation, paracetamol (tylenol arthritis), ibuprofen for arthritis infective and its symptoms, requiring a walker and an application in for a scooter for dysstasia and gait disturbance.At time of reporting, the outcome was not recovered for all events.Seriousness criteria: medically significant for arthritis infective , disability for all events.A product technical complaint (ptc) was initiated on 31-may-2023 for synvisc (lot/batch number: unknown) with global ptc number: 100332222.The sample status of the ptc was not available.The final investigation was not yet completed (till 01-jun-2023), it was set in process.Additional information was received on 31-may-2023 by quality department: ptc initiating details added; strength added; text amended.

Event Description

Difficulty getting up [difficulty in standing].This could be an infection (knee) [joint infection].Difficulty getting up and walking [walking difficulty].Inflammation (knee) [injection site joint inflammation] ([injection site joint discomfort], [injection site joint pain], [condition aggravated], [stiff knees], [injection site joint swelling]).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 to cases and 2023sa168715, 2023sa171546 and 2023sa167811 (multiple device suspect used for the same patient).This case involves 57 years old female patient who had difficulty getting up and walking and this could be an infection and inflammation (knee), while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included she took received synvisc-one a couple of years ago and had no issues.She added that she knew that there was a synvisc-one recall in 2017.She requests additional information regarding this.She asked if there was a current recall.Spoke per fda (food and drug administration) website in regard to additional details of the synvisc-one recall.Added that there was no information regarding a recall at this time and the exp date of the recalled lot expired in 2020.The patient's past medical history, and family history were not provided.On 10-apr-2023 the patient received the first injection and on 17-apr-2023, the patient received the second injection of synvisc (hylan g-f 20, sodium hyaluronate) series.On 24-apr-2023, the patient received the third injection (liquid solution) of synvisc (hylan g-f 20, sodium hyaluronate) series of strength: 16 mg/2 ml at weekly frequency (with an unknown dose, route, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.The patient developed a worsening of knee pain (injection site joint pain and condition aggravated), swelling (injection site joint swelling), inflammation (injection site joint inflammation), stiffness (joint stiffness), increased pressure of the knee (injection site joint discomfort), and difficulty getting up (dysstasia) and walking (gait disturbance).She had been treating this with ice, elevation, tylenol arthritis, and ibuprofen, however the symptoms were not resolving.The patient was now requiring a walker and had an application in for a scooter.The patient had been in touch with her health-care professional and has an appointment on 05-jun-2023.She has spoken with the nurse last week and today.The patient was concerned that this could be an infection (arthritis infective).Action taken: not applicable for all events.Corrective treatment: the patient was treated with ice, elevation, paracetamol (tylenol arthritis), ibuprofen (ibuprofen), now requiring a walker for injection site joint inflammation and difficulty getting up and walking, not reported for this could be an infection (knee) at time of reporting, the outcome was not recovered for all events.Seriousness criteria: medically significant for arthritis infective, disability for rest all events a product technical complaint (ptc) was initiated on 31-may-2023 for synvisc (lot/batch number: unknown) with global ptc number: 100332222 the sample status of the ptc was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class had been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the nonconforming material or product process.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 16-jun-2023 and the summarized conclusion was "no assessment possible." additional information was received on 31-may-2023 by quality department: ptc initiating details added; strength added; text amended.Additional information was received on 16-jun-2023 by quality department (healthcare professional): ptc investigation summary added.Text 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: 17071667
• MDR Text Key: 316752013
• Report Number: 2246315-2023-00062
• 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: 06/21/2023

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 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: 06/06/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/08/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Disability; Required Intervention
• Patient Sex: Female