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 Fever (1858); Synovitis (2094); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 02/13/1999

Event Type  Injury  

Event Description

Acute synovitis [acute synovitis] ([arthralgia aggravated], [swelling of l knee], [stiff knees], [effusion of knee], [febrile reaction]).Case narrative: initial information received from a pharmacist on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097756.This case involves a female patient who experienced acute synovitis, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient received full series x3 doses of 8 ml/cc hylan g-f 20, sodium hyaluronate via intra-articular route (dosage, frequency, lot, indication: unknown) in left knee.She received the last dose of synvisc in 1999.On (b)(6) 1999, after unknown latency, the patient called complaining of increased pain (arthralgia), swelling (joint swelling) and stiffness in her knee (joint stiffness).She had been febrile 'off and on' since morning (pyrexia).She was seen in clinic for evaluation of left knee.There was no fluid aspirated, no erythema and it was not suggestive of infection; however there was slight effusion (joint effusion).The assessment was concluded with diagnosis of acute synovitis (medically significant).Action taken: not applicable.Corrective treatment: not reported.Outcome: unknown.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc, batch number: unknown with global ptc 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 was identified and mitigated through the ncr process.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.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation was completed on 21-jan-2021.Follow up was received on 08-jan-2021 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 21-jan-2021 from healthcare professional.Global ptc results were 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: 11249433
• MDR Text Key: 233155573
• Report Number: 2246315-2021-00047
• 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
• Report Date: 01/29/2021

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 Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2021
• 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