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

Lot Number CRSP002

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

Patient Problem Synovitis (2094)

Event Type  Injury  

Event Description

Chronic synovitis on gonarthrosis (right knee) [synovitis chronic] ([effusion (r) knee], [aching (r) knee]).Case narrative: this case is linked to case 2022sa270592, 2022sa269585, 2022sa269318, 2022sa269594, and 2022sa270411 (multiple devices).Initial information was received on 05-jul-2022 regarding a solicited valid serious case from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: 68618; country:(b)(6).Study title: patient support program involving synvisc.This case involves a 61 years old male patient who had chronic synovitis on gonarthrosis (right knee) 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.The patient had ongoing gonarthrosis with presence of calcium pyrophosphate.Concomitant medication included triamcinolone acetonide (kenalog).On an unknown date, the patient started receiving synvisc (hylan g-f 20, sodium hyaluronate, 16 mg/2ml) injection at dose of 2 ml 3x as lateral injection in stretched/extended right knee (lot - crsp002, unknown expiry date, strength) for osteoarthritis grade ii.Last injection was on (b)(6) 2022.Since an unknown date, after unknown latency, he occasionally got a little water in his knees, especially in his left knee (joint effusion, mild, intervention required).When the patient went to the physician on tuesday, (b)(6) 2022, he received synvisc injections in his right knee.Also, on (b)(6) 2022, doctor gave 21 ml citrin by puncture in knee (not specified) and on (b)(6) 2022, gave 20 mg kenolog, puncture 7ml citrin and synvisc 6 ml.He did not know when he got the water only knew that his knee hurt (arthralgia, mild, intervention required).It was unknown if the patient experienced any additional symptoms/events.It is unknown if there were lab data/results available.Upon follow up, hcp confirmed that he patient had water in knees due to chronic synovitis on gonarthrosis (synovitis, intervention required, mild).The treatment with synvisc had not contributed to the reported events and the reported events were due to the pre-existing condition of gonarthrosis with presence of calcium pyrophosphate.Medical management of events was done with corticosteroids puncture.This was not an adverse effect of synvisc.Action taken: not applicable.Corrective treatment: corticosteroids puncture.At time of reporting, the outcome was recovering.Reporter causality: not related.Company causality: not reportable.Product technical complaint (ptc) was initiated with global ptc number 100241038 on (b)(6)2022 for synvisc.Batch number: crsp002 and results were pending for the same.Based on the information previously received, the linking for event water in the knee was updated to effusion (r) knee additional information was received on (b)(6) 2022 from other healthcare professional.This case previously assessed as non-serious was upgraded to serious because the patient had received corticosteroids puncture for management of reported events.Case became medically confirmed.Event added- chronic synovitis on gonarthrosis.Events- occasionally got a little water in his knees (right knee) and knee hurt (right knee) were considered as symptoms of synovitis; their outcome, intensity, reporter causality was updated.Strength and global ptc number was added.Clinical course was updated.Text was amended accordingly.

Event Description

Chronic synovitis on gonarthrosis (right knee) [synovitis chronic] ([effusion (r) knee], [aching (r) knee]).Case narrative: initial information was received on 05-jul-2022 regarding a solicited valid serious case from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: (b)(6); country: canada.Study title: patient support program involving synvisc.This case is linked to case (b)(4) (multiple devices).This case involves a 61 years old male patient who had chronic synovitis on gonarthrosis (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) and family history were not provided.The patient had ongoing gonarthrosis with presence of calcium pyrophosphate.Concomitant medication included triamcinolone acetonide (kenalog).On an unknown date, the patient started receiving synvisc (hylan g-f 20, sodium hyaluronate, strength: 16 mg/2ml, injection at dose of 2 ml 3x (thrice) as lateral injection in stretched/extended right knee (lot - crsp002, expiry date: 31-dec-2024) for osteoarthritis grade ii.Last injection was on (b)(6) 2022.Since an unknown date, after unknown latency, he occasionally got a little water in his knees, especially in his left knee (joint effusion, mild, intervention required).When the patient went to the physician on tuesday, (b)(6) 2022, he received synvisc injections in his right knee.Also, on (b)(6) 2022, doctor gave 21 ml citrin by puncture in knee (not specified) and on (b)(6) 2022, gave 20 mg kenolog, puncture 7ml citrin and synvisc 6 ml.He did not know when he got the water only knew that his knee hurt (arthralgia, mild, intervention required).It was unknown if the patient experienced any additional symptoms/events.It is unknown if there were lab data/results available.Upon follow up, hcp (health care professional) confirmed that he patient had water in knees due to chronic synovitis on gonarthrosis (synovitis, intervention required, mild).The treatment with synvisc had not contributed to the reported events and the reported events were due to the pre-existing condition of gonarthrosis with presence of calcium pyrophosphate.Medical management of events was done with corticosteroids puncture.This was not an adverse effect of synvisc.Action taken: not applicable for the event.Corrective treatment: corticosteroids puncture for the event.At time of reporting, the outcome was recovering for the event.Reporter causality: not related for the event.Company causality: not reportable for the event.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 06-jul-2022 for synvisc.Batch number: crsp002, expiry: 31-dec-2024 and sample status was not available.The production and quality control documentation for lot # crsp002 expiration date (2024-12) was reviewed.The investigation showed that the product met specifications.No associated non- conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsp002 no capa (corrective and preventive action) is required.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.As of 8sep22 there are 3 complaints on file for lot# crsp002 and all related sublots.3 complaints are on file for lot#crsp002a: (3) adverse event reports.Sanofi will continue to monitor adverse events to determine if a capa is required.The final investigation was completed on 12-sep-2022 with summarized conclusion as no assessment possible.Based on the information previously received, the linking for event water in the knee was updated to effusion (r)(right) knee.Additional information was received on 22-jul-2022 from other healthcare professional.This case previously assessed as non-serious was upgraded to serious because the patient had received corticosteroids puncture for management of reported events.Case became medically confirmed.Event added- chronic synovitis on gonarthrosis.Events- occasionally got a little water in his knees (right knee) and knee hurt (right knee) were considered as symptoms of synovitis; their outcome, intensity, reporter causality was updated.Strength and global ptc number was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 12-sep-2022 from quality department via other health professional.Ptc results and expiry date was updated.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 15161740
• MDR Text Key: 297207099
• Report Number: 2246315-2022-00089
• 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,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

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: Health Professional
• Device Lot Number: CRSP002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2022
• 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
• Treatment: KENALOG [TRIAMCINOLONE ACETONIDE],UNKNOWN; KENALOG [TRIAMCINOLONE ACETONIDE],UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Sex: Male