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

Event Type  Injury  

Event Description

Synviscone taken out of the knee [knee effusion], swelling [swelling].Case narrative: initial information received on 21-sep-2021 regarding an unsolicited valid serious case received from a physician from united states.This case involves a (b)(6) female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and reported synvisc one taken out of the knee and swelling.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (lot, dose, route, formulation, strength: unknown) for pain of the knee and osteoarthritis.On the next day patient complained of swelling (latency: 1 day).Patient went to the physician's off to three days later to get hylan g-f 20, sodium hyaluronate taken out of the knee (joint effusion; seriousness: intervention required) (latency: 3 days).Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (swelling, synvisc one taken out of the knee).At time of reporting, the outcome was recovering / resolving for both events.

Event Description

Synviscone taken out of the knee [knee effusion].Swelling [swelling].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a physician from united states.This case involves a 59 year old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and reported synvisc one taken out of the knee and swelling.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (formulation: injection; strength: 48 mg/ 6 ml) for once (lot number, dose, route: unknown) for pain of the knee and osteoarthritis.On the next day patient complained of swelling (latency: 1 day).Patient went to the physician's off to three days later to get hylan g-f 20, sodium hyaluronate taken out of the knee (joint effusion; seriousness: intervention required) (latency: 3 days).Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (swelling, synvisc one taken out of the knee).At time of reporting, the outcome was recovering / resolving for both events.A product technical compliant was initiated on (b)(6) 2021 with global ptc number: (b)(4) and results were pending for same.Additional information was received on 23-sep-2021 from quality department.Global ptc number and strength and formulation added.Clinical course updated and text amended accordingly.

Event Description

Synviscone taken out of the knee [knee effusion].Swelling [swelling].Case narrative: initial information received on 21-sep-2021 regarding an unsolicited valid serious case received from a physician from united states.This case involves a 59 year old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and reported synvisc one taken out of the knee and swelling.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (formulation: injection; strength: 48 mg/ 6 ml) for once (lot number, dose, route: unknown) for pain of the knee and osteoarthritis.On the next day patient complained of swelling (latency: 1 day).Patient went to the physician's off to three days later to get hylan g-f 20, sodium hyaluronate taken out of the knee (joint effusion; seriousness: intervention required) (latency: 3 days).Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (swelling, synvisc one taken out of the knee).At time of reporting, the outcome was recovering / resolving for both events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one.Batch number: unknown; comet compliant id number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Final investigation complete date was (b)(6) 2021.No safety issues were indicated in this review.Additional information was received on 23-sep-2021 from quality department.Global ptc number and strength and formulation added.Clinical course updated and text amended accordingly.Additional information was received on 12-oct-2021 from the quality department.Ptc number added.Clinical course updated and text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12530864
• MDR Text Key: 282769378
• Report Number: 2246315-2021-00158
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR