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 Synovitis (2094); Arthralgia (2355); Joint Swelling (2356)

Event Date 01/01/1999

Event Type  Injury  

Event Description

Acute synovitis, synovitis from injections in right knee [acute synovitis] ([knee effusion], [aching (r) knee], [joint stiffness], [knee swelling]).Case narrative: this case is related to case: (b)(4) (multiple devices).Initial information was received on 08-jan-2021 regarding an unsolicited valid non-serious case from a pharmacist via 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 the unknown date of 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 (joint effusion) 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.Outcome: unknown for acute synovitis, synovitis from injections in right knee.A product technical compliant was initiated with comet complaint id (b)(4) and results were pending for same.

Event Description

Acute synovitis, synovitis from injections in right knee [acute synovitis].([arthrocentesis], [knee effusion], [aching (r) knee], [joint stiffness], [knee swelling]).Case narrative: this case is related to case: (b)(4) (multiple devices).Initial information was received on 08-jan-2021 regarding an unsolicited valid non-serious case from a pharmacist via 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) injection, liquid (solution) (16mg/2 ml) 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 the unknown date of 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) (seriousness criteria: medically significant and intervention required).Aspirated fluid from knee (joint effusion) for aerobic/anaerobic cultures (aspiration joint).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.Outcome: unknown for acute synovitis, synovitis from injections in right knee 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: 04-aug-2021.Additional information was received on 04-aug-2021 from other healthcare professional.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
• MDR Report Key: 11289646
• MDR Text Key: 230791296
• Report Number: 2246315-2021-00061
• 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
• Report Date: 08/09/2021

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: 02/05/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention