MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number ARSL019B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Joint was aspirated [joint aspiration].Feeling increasing pain [arthralgia aggravated].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a physician from (b)(6).This case is linked to case (b)(4) (same patient).This case involves male patient who was feeling increasing pain and joint was aspirated 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.On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate injection (frequency, dose, route and indication: unknown) (lot - arsl019b with unknown expiration date) in left knee.On an unknown date of (b)(6) 2021, after unknown latency patient was feeling increasing pain in knee (arthralgia).On an unknown date in 2021, after unknown latency the left knee joint was aspirated (aspiration joint).Analysis of left knee revealed no bacteria.Both the events were assessed as serious with seriousness criteria of intervention required.Action taken: not applicable for both events.Corrective treatment: not reported for both events.Outcome: unknown for both events.

Event Description

Joint was aspirated [joint aspiration].Feeling increasing pain [arthralgia aggravated].Case narrative: initial information received on 01-oct-2021 regarding an unsolicited valid serious case received from a physician from canada.This case is linked to case (b)(4) (same patient).This case involves male patient who was feeling increasing pain and joint was aspirated 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.On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate solution for injection (strength: 16 mg/ 2 ml) ( (frequency, dose, route and indication: unknown); (lot - arsl019b; expiry date: apr-2022) in left knee.On an unknown date of (b)(6) 2021, after unknown latency patient was feeling increasing pain in knee (arthralgia).On an unknown date in 2021, after unknown latency the left knee joint was aspirated (aspiration joint).Analysis of left knee revealed no bacteria.Both the events were assessed as serious with seriousness criteria of intervention required.Action taken: not applicable for both events.Corrective treatment: not reported for both events.Outcome: unknown for both events.A product technical complaint (ptc) was initiated for synvisc with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number; unknown.Sample status: not available.The production and quality control documentation for lot number arsl019b; expiration date (2023-04) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsl019b no capa was required.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.This review had not indicated any safety issue.As of 01-nov-2021 there were 7 complaints on file for lot number arsl019 and all related sublots.1 complaint was on file for lot number: arsl019c: (1) tips breakage.6 complaints were on file for lot number: arsl019b: (6) adverse event reports.Sanofi will continue to monitor adverse events to determine if a capa was required final investigation complete date: 01-nov-2021 with summary code as no assessment possible.Additional information was received on 01-nov-2021 from the quality department.Global ptc number and ptc results added.Formulation and strength 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: 12622455
• MDR Text Key: 277613551
• Report Number: 2246315-2021-00164
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: ARSL019B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Sex: Male