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 Synovitis (2094)

Event Date 07/26/2021

Event Type  Injury  

Event Description

Synovitis reactive to synvisc one [synovitis] ([effusion], [synovial fluid polymorphonuclear leukocyte positive]), degenerative femorotibial changes [degenerative bone disease], high rheumatoid factor at 75.34 (0-30) [rheumatoid factor increased].Case narrative: initial information received on 10-sep-2021 and 13-sep-2021 (processed together with clock start date of (b)(6) 2021) regarding an unsolicited valid serious case received from a physician from (b)(6).This case involves a (b)(6) male patient who experienced synovitis reactive to hylan g-f 20, sodium hyaluronate [synvisc one] and later degenerative femorotibial changes were noted along with high rheumatoid factor at 75.34 (0-30).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection at a dose 1 dosage form once via intra-articular route in right knee (lot, strength: unknown) for arthrosis.On (b)(6) 2021 the patient developed effusion 28 days after starting use of hylan g-f 20 and sodium hyaluronate due to which 50 cc of fluid was withdrawn via arthrocentesis and descending series of oral corticosteroids for 3 weeks was started.This event was leading to intervention.On (b)(6) 2021 50 cc; of fluid was withdrawn via arthrocentesis with corticoanesthetic infiltration followed by withdrawal of 80 cc of fluid via arthrocentesis with corticoanesthetic infiltration and nonsteroidal anti-inflammatory drugs (nsaids).On (b)(6) 2021, 60 cc fluid via arthrocentesis with corticoanesthetic infiltration and nonsteroidal anti-inflammatory drugs (nsaids).On an unknown date in 2021 there was relapse of effusion with synovitis reactive to hylan g-f 20, sodium hyaluronate (synovitis).Evacuation of effusion was done with corticoanesthetic infiltration, oral corticosteroids by arthrocentesis of more than 50 cc in each evacuation.Analysis of synovial fluid revealed: leucocytes of 13760, 83% polynuclear (synovial fluid white blood cells positive; latency: unknown), crystal negative and culture negative.Magnetic resonance imaging (mri) done on (b)(6) 2021 (latency: 1 month 27 days) showed degenerative femorotibial changes (degenerative bone disease).On an unknown date in 2021 blood test was normal except for high rheumatoid factor at 75.34 (0-30) (rheumatoid factor increased; latency: unknown).Repeat test on analysis of synovial fluid revealed: 15232 leucocytes and negative cultures.Relevant laboratory test results included: magnetic resonance imaging - on (b)(6) 2021: [degenerative femorotibial changes] rheumatoid factor (0 - 30) - in 2021: 75.34 [blood test normal, except for rheumatoid factor being high at 75.34 (0-30)].Synovial fluid analysis - in 2021: [leucocytes 13760, 83% polynuclear, crystal negative, culture negative.Leucocytes 13760, 83% polynuclear]; in 2021: negative culture.Synovial fluid cell count - in 2021: 13760 [13760 (83% polynuclear)]; in 2021 (15232 leucocytes).Action taken: not applicable for all events.Corrective treatment: arthrocentesis, nsaids, oral corticosteroid and corticoanesthetic infiltration was received for the events (effusion, synovitis reactive to synvisc one, analysis of synovial fluid: leucocytes 13760, 83% polynuclear).It was not reported if the patient received a corrective treatment for the event (degenerative femorotibial changes).At time of reporting, the outcome was unknown for the event synovitis reactive to synvisc one and was unknown for the event degenerative femorotibial changes.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 13-sep-2021 for product.Batch number; unknown; sample status: not available.The investigation was in process.

Event Description

Synovitis reactive to synvisc one [synovitis] ([effusion], [synovial fluid polymorphonuclear leukocyte positive]) degenerative femorotibial changes [degenerative bone disease] high rheumatoid factor at 75.34 (0-30) [rheumatoid factor increased] case narrative: initial information received on 10-sep-2021 and 13-sep-2021 (processed together with clock start date of 10-sep-2021) regarding an unsolicited valid serious case received from a physician from spain.This case involves a 63 years old male patient who experienced synovitis reactive to hylan g-f 20, sodium hyaluronate [synvisc one] and later degenerative femorotibial changes were noted along with high rheumatoid factor at 75.34 (0-30).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate (strength: 48/ 6 ml) injection at a dose 1 dosage form once via intra-articular route in right knee (lot: unknown) for arthrosis.On (b)(6) 2021 the patient developed effusion 28 days after starting use of hylan g-f 20 and sodium hyaluronate due to which 50 cc of fluid was withdrawn via arthrocentesis and descending series of oral corticosteroids for 3 weeks was started.This event was leading to intervention.On (b)(6) 2021 50 cc; of fluid was withdrawn via arthrocentesis with corticoanesthetic infiltration followed by withdrawal of 80 cc of fluid via arthrocentesis with corticoanesthetic infiltration and nonsteroidal anti-inflammatory drugs (nsaids).On an unknown date in 2021 there was relapse of effusion with synovitis reactive to hylan g-f 20, sodium hyaluronate (synovitis).Evacuation of effusion was done with corticoanesthetic infiltration, oral corticosteroids by arthrocentesis of more than 50 cc in each evacuation.Analysis of synovial fluid revealed: leucocytes of 13760, 83% polynuclear (synovial fluid white blood cells positive; latency: unknown), crystal negative and culture negative.Magnetic resonance imaging (mri) done on 25-aug-2021 (latency: 1 month 27 days) showed degenerative femorotibial changes (degenerative bone disease).On an unknown date in 2021 blood test was normal except for high rheumatoid factor at 75.34 (0-30) (rheumatoid factor increased; latency: unknown).Repeat test on analysis of synovial fluid revealed: 15232 leucocytes and negative cultures.On 02-sep-2021, 60 cc fluid via arthrocentesis with corticoanesthetic infiltration and nonsteroidal anti-inflammatory drugs (nsaids).Relevant laboratory test results included: magnetic resonance imaging - on 25-aug-2021: [degenerative femorotibial changes] rheumatoid factor (0 - 30) - in 2021: 75.34 [blood test normal, except for rheumatoid factor being high at 75.34 (0-30)] synovial fluid analysis - in 2021: [leucocytes 13760, 83% polynuclear, crystal negative, culture negative leucocytes 13760, 83% polynuclear]; in 2021: negative culture synovial fluid cell count - in 2021: 13760 [13760 (83% polynuclear)]; in 2021 (15232 leucocytes) action taken: not applicable for all events.Corrective treatment: arthrocentesis, nsaids, oral corticosteroid and corticoanesthetic infiltration was received for the events (effusion, synovitis reactive to synvisc one, analysis of synovial fluid: leucocytes 13760, 83% polynuclear).It was not reported if the patient received a corrective treatment for the event (degenerative femorotibial changes).At time of reporting, the outcome was unknown for the event synovitis reactive to synvisc one and was unknown for the event degenerative femorotibial changes.A product technical complaint (ptc) was initiated on 13-sep-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 (corrective and preventive action) 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 (nonconformance 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 safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Final investigation complete date was 30-sep-2021.No safety issues were indicated in this review.Additional information was received on 30-sep-2021 from the quality department.Ptc results added.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: 12516382
• MDR Text Key: 282769303
• Report Number: 2246315-2021-00151
• 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
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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