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

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 02-jun-2023: this case involves a 57 years old female patient who had difficulty getting up and walking, this could be an infection (knee), inflammation (knee) and stiffness (knee) while being treated with the use of medical device while being treated with the use of 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].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], [injection site joint swelling]).Stiffness (knee) [stiff knees].Case narrative: initial information received on 31-may-2023 from united states regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves a 57 years old female patient who had difficulty getting up and walking, this could be an infection (knee), inflammation (knee) and stiffness (knee) while being treated with the use of medical device while being treated with the use of 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 started using synvisc (hylan g-f 20, sodium hyaluronate) injection qw (unknown dose, strength, frequency, route, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.Caller stated that she took received synvisc-one a couple of years ago and had no issues.The patient received 3 injections a week apart of synvisc from (b)(6)2023 with unknown latency (onset: 2023) (unknown latency) and developed a worsening of knee pain (injection site joint pain), 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 and walking (gait disturbance) (dysstasia).She had been treating this with ice, elevation, tylenol arthritis, and ibuprofen, however the symptoms were not resolving.The patient now requiring a walker and had an application in for a scooter.The patient had been in touch with her hcp (healthcare professional) and had an appointment on (b)(6)2023.She had spoken with the nurse last week and today.The patient was concerned that this could be an infection (arthritis infective).Action taken: no action taken for all events.Corrective treatment: the patient was treated with paracetamol (tylenol arthritis), ibuprofen (ibuprofen) for dysstasia, gait disturbance and injection site joint inflammation and not reported for other events.Outcome : not recovered / not resolved for all the events.Seriousness criteria: disable for all events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

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], [injection site joint swelling], [stiff knees], [condition aggravated]).Case narrative: initial information received on 31-may-2023 from united states regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves a 57 years old female patient who had difficulty getting up and walking, this could be an infection (knee), inflammation (knee) and stiffness (knee) while being treated with the use of medical device while being treated with the use of 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 started using synvisc (hylan g-f 20, sodium hyaluronate) injection of strength 16 mg/2 ml qw(weekly) (unknown route, dose, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.The patient received 3 injections a week apart of synvisc (b)(6) 2023.On an unknown date in 2023 (latency: unknown), 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 had spoken with the nurse last week ((b)(6) 2023) and today ((b)(6) 2023).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: no action taken 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).Outcome : not recovered / not resolved for all the events.Seriousness criteria: disable for all events except medically significant for arthritis infective a product technical complaint (ptc) was initiated on 31-may -2023 for synvisc (lot/batch number: unknown) with global ptc number: 100332130.The sample status of the ptc was not available.The final investigation was not yet completed (till (b)(6) 2023), it was set in process.Additional information was received on 31-may-2023 by quality department: ptc details and strength added.Upon internal review, clinical details 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], [injection site joint swelling], [stiff knees], [condition aggravated]) case narrative: initial information received on 31-may-2023 from united states regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple device suspect used for the same patient).This case involves a 57 years old female patient who had difficulty getting up and walking, this could be an infection (knee), inflammation (knee) and stiffness (knee) while being treated with the use of medical device while being treated with the use of 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 started using synvisc (hylan g-f 20, sodium hyaluronate) injection (liquid solution) of strength 16 mg/2 ml qw (weekly) (unknown route, dose, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.The patient received 3 injections a week apart of synvisc from (b)(6) 2023.On an unknown date in 2023 (latency: unknown), 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 had spoken with the nurse last week ((b)(6) 2023) and today ((b)(6) 2023).The patient was concerned that this could be an infection (arthritis infective).Action taken: no action taken 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) outcome not recovered / not resolved for all the events seriousness criteria: disability for all events except medically significant for arthritis infective a product technical complaint (ptc) was initiated on 31-may-2023 for synvisc (lot/batch number: unknown) with global ptc number: 100332130.The sample of the ptc (product technical complaint) 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 details and strength added.Upon internal review, clinical details added.Text amended.Additional information was received on 16-jun-2023 from quality department (other healthcare professional).Ptc investigation summary added.Text amended accordingly.

• 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: 17059028
• MDR Text Key: 316510721
• Report Number: 2246315-2023-00059
• 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: 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: 06/05/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/07/2023; 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
• Patient Sex: Female