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

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

Patient Problems Pain (1994); Synovitis (2094); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/28/1999

Event Type  Injury  

Event Description

Acute synovitis, synovitis from injections in right knee [acute synovitis] ([aching (r) knee], [joint stiffness], [swelling of r knee]).Case narrative: this case is submitted following an incorrect worldwide id in case id ((b)(4)) which will be deleted.This report contains no new information.Initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a pharmacist health authorities of united states under reference mw5097752.This case involves an adult female patient who experienced acute synovitis, synovitis from injections in right knee, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date in 1999, the patient received first injection of synvisc (hylan g-f 20, sodium hyaluronate) (8 mg/cc) series via intra-articular route in right knee (dose, frequency, indication and lot - unknown).Information on batch number was requested.Patient received full series of synvisc in right knee.On (b)(6) 1999, after known latency, the patient called in because she had wakened with knee acutely swollen (joint swelling) and stiffness (joint stiffness), but no redness or fever.The patient came in for follow up visit.The patient was with synovitis from injections (synovitis; medically significant).Aspirated fluid from knee for aerobic/anaerobic cultures.On follow up visit: knee was less swollen, there was reduced pain (arthralgia); latency: unknown.Reports of aerobic/anaerobic cultures were negative (5 days).There were no synovial crystals.Assessment was acute synovitis (synovitis).Action taken: no action taken.It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovering / resolving a product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 22-jan-2021 follow up information received on 11-jan-2021 from healthcare professional.Global ptc number was added.Additional information was received on 22-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.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: 11974137
• MDR Text Key: 267362349
• Report Number: 2246315-2018-00883
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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