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 Arthritis (1723)

Event Date 03/01/2022

Event Type  Injury  

Event Description

A little inflammation (right knee) [injection site joint inflammation] ([injection site joint pain], [injection site joint discomfort]).No improvement; does not feel an extreme improvement (lack of efficacy) with no reported advers event [device ineffective].Case narrative: initial information received on (b)(6) 2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).Country: peru.This case is linked to case (b)(6) (multiple devices suspect for same patient; other knee).This case involves a 65 years old female patient who experienced a little inflammation (right knee) and no improvement; does not feel an extreme improvement (lack of efficacy) with no reported adverse event while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing knee pain.The patient did not suffer from other illnesses and does not take any other medications.On (b)(6) 2022, the patient started using hylan g-f 20, sodium hyaluronate, solution for injection (liquid, solution) at a dose of 6 ml in both knees (strength 48mg/6ml) (with an unknown frequency, route.Batch number and expiration date) for knee pain and meniscus injury.The patient received synvisc one 6 ml hyaluronic acid on her on (b)(6) 2022, in both knees (medical indication: knee pain) but she still feels pain, she was on the eighth day and there was no improvement (device ineffective), since they put it on her, he felt like a weight on her knees (injection site joint discomfort, required intervention and medically significant).After 8 days she does not feel an extreme improvement (lack of efficacy) (device ineffective).The patient indicated that the product had not had the effect she expected, given that despite having applied synvisc one she had felt a lot of pain (injection site joint pain), for which the doctor told her to take anti-inflammatory analgesics (the names were not specified) for 1 week (from (b)(6) 2022), betaduo (injectable betamethasone) was also applied for 3 days ((b)(6) 2022).Moviflex was currently being applied as a spray (indomethacin, every 8 hours), but she still feels pain and a little inflammation (injection site joint inflammation, required intervention and medically significant; onset: (b)(6) 2022; latency few days), but with less intensity.No other dose of synvisc one had been administered.The patient, when consulted for her diagnosis, indicates that she had a meniscus injury (diagnosed by magnetic resonance imaging), feeling more pain in her right knee than in her left.The reporter does not provide further information.Action taken: not applicable for both the events.Corrective treatment: anti-inflammatory analgesics (the names are not specified), betaduo (injectable betamethasone), moviflex (indomethacin) for injection site joint inflammation.Outcome: unknown for the event device ineffective and was recovering / resolving for the event a little inflammation (right knee).A product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc one (batch number and expiry date: unknown) with global ptc number: (b)(4).The sample of the ptc (product technical complaint) was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction, 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 has 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 (b)(6) 2023 and the summarized conclusion was "no assessment possible." additional information was received on 29-mar-2022 from the patient.Event of pain in the right knee/ pain on injection site was added.Text amended accordingly.Based on information previously received on 29-mar-2022, the following information: event of injection site joint inflammation was added and pt coding for injection site joint pain and injection site joint discomfort were updated and they were made symptoms.The case became serious.Text amended accordingly.Additional information was received on 14-sep-2023 from healthcare professional via quality department.Strength, global ptc number and investigation summary details 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: 17756170
• MDR Text Key: 323510889
• Report Number: 2246315-2023-00095
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2023
• 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; Required Intervention
• Patient Sex: Female