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

Lot Number ARSP008E

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

Patient Problem Synovitis (2094)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2022: this case involves a 61 years old male patient who had chronic synovitis on gonarthrosis (left knee), while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc] for osteoarthritis.Based on the available information, causal relationship between the events and suspect product could not be established due to underlying condition being considered as the major factor for occurrence of events.However, further information regarding patient¿s medical history, past medications, concomitant medications, and other risk factors would aid in better case assessment.

Event Description

Chronic synovitis on gonarthrosis (left knee) [synovitis chronic] ([arthrocentesis], [effusion (l) knee], [aching (l) knee]).Case narrative: this case is linked to case (b)(4) (multiple devices).Initial information was received on (b)(6) 2022 from a patient and follow up information on (b)(6) 2022 from other healthcare professional (processed together) regarding a solicited valid serious case, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: (b)(6); 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 (left knee), while being treated with 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.It was unknown if the patient had any medical history, or risk factor.At the time of the event, the patient had ongoing gonarthrosis with presence of calcium pyrophosphate.On an unknown date, the patient started receiving synvisc (hylan g-f 20, sodium hyaluronate, 16 mg/2 ml) injection at dose of 2 ml thrice as lateral injection in stretched/extended left knee (lot - arsp008e; expiry date: unknown) for osteoarthritis grade ii.Last injection in left knee was on (b)(6) 2021.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.The physician then removed the water (aspiration joint, mild, intervention required) and injected cortizone in his left knee and rescheduled his appointment to a later date for the left 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.The patient was treated with hydrocortisone acetate (cortizone [hydrocortisone acetate]).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 (b)(4) on (b)(6) 2022 for synvisc.Batch number: arsp008e and the results were pending for the same.

Event Description

Chronic synovitis on gonarthrosis (left knee) [synovitis chronic] ([arthrocentesis], [effusion (l) knee], [aching (l) knee]) case narrative: this case is linked to case 2022sa270592, 2022sa270596, 2022sa269318, 2022sa269594, and 2022sa270411 (multiple devices).Initial information was received on 05-jul-2022 from a patient and follow up information on 22-jul-2022 from other healthcare professional (processed together) regarding a solicited valid serious case, 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 involves a 61 years old male patient who had chronic synovitis on gonarthrosis (left knee), while being treated with 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.It was unknown if the patient had any medical history, or risk factor.At the time of the event, the patient had ongoing gonarthrosis with presence of calcium pyrophosphate.On an unknown date, the patient started receiving synvisc (hylan g-f 20, sodium hyaluronate), 16 mg/2 ml) injection at dose of 2 ml thrice as lateral injection in stretched/extended left knee (lot - arsp008e; expiry date: 31-mar-2023) for osteoarthritis grade ii.Last injection in left knee was on (b)(6) 2021.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.The physician then removed the water (aspiration joint, mild, intervention required) and injected cortizone in his left knee and rescheduled his appointment to a later date for the left 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 the 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 the patient was treated with hydrocortisone acetate (cortizone) 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 100241022 on (b)(6) 2022 for synvisc.Batch number: arsp008e; expiry date: 31-mar-2023.Ptc site sample was not available.Ptc stated: the production and quality control documentation for lot number arsp008e expiration date (2023-03) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsp008e 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 22aug2022 there are 8 complaints on file for lot number arsp008 and all related sublots.8 complaints are on file for lot number arsp008e: (2) broken syringes, (5) adverse event reports and (1) extrusion issue/adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.The final investigation was completed on 02-sep-2022 with summarized conclusion as no assessment possible.Additional information was received on 02-sep-2022 from other healthcare professional (from quality department).Gptc results were received and added.Text was amended accordingly.

Manufacturer Narrative

Sanofi company comment for follow up dated 02-sep-2022: follow up information received does not change prior case assessment.This case involves a 61 years old male patient who had chronic synovitis on gonarthrosis (left knee), while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc] for osteoarthritis.Based on the available information, causal relationship between the events and suspect product could not be established due to underlying condition being considered as the major factor for occurrence of events.However, further information regarding patient¿s medical history, past medications, concomitant medications, and other risk factors would aid in better case assessment.

Event Description

Chronic synovitis on gonarthrosis (left knee) [synovitis chronic] ([arthrocentesis], [effusion (l) knee], [aching (l) knee]) case narrative: this case is linked to case (b)(4) (multiple devices suspect for same patient).Initial information was received on 05-jul-2022 from a patient and follow up information on 22-jul-2022 from other healthcare professional (processed together) regarding a solicited valid serious case, 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 involves a 61 years old male patient who had chronic synovitis on gonarthrosis (left knee), while being treated with 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.It was unknown if the patient had any medical history, or risk factor.At the time of the event, the patient had ongoing gonarthrosis with presence of calcium pyrophosphate.On an unknown date, the patient started receiving synvisc (hylan g-f 20, sodium hyaluronate), 16 mg/2 ml) injection at dose of 2 ml thrice as lateral injection in stretched/extended left knee (lot - arsp008e; expiry date: 31-mar-2023) for osteoarthritis grade ii.Last injection in left knee was on (b)(6) 2021.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.The physician then removed the water (aspiration joint, mild, intervention required) and injected cortizone in his left knee and rescheduled his appointment to a later date for the left 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 the 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 the patient was treated with hydrocortisone acetate (cortizone) 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 (b)(4) on 06-jul-2022 for synvisc.Batch number: arsp008e; expiry date: 31-mar-2023.Ptc site sample was not available.Ptc stated: the production and quality control documentation for lot number arsp008e expiration date (2023-03) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsp008e 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 22aug2022 there are 8 complaints on file for lot number arsp008 and all related sublots.8 complaints are on file for lot number arsp008e: (2) broken syringes, (5) adverse event reports and (1) extrusion issue/adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.The final investigation was completed on 02-sep-2022 with summarized conclusion as no assessment possible.Additional information was received on 02-sep-2022 from other healthcare professional (from quality department).Gptc results were received and added.Text was amended accordingly.Based on the information previously received, the eu-ca field has been inactivated since as per device algorithm none of the criteria for reportable incident is met.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: 15161578
• MDR Text Key: 297209914
• Report Number: 2246315-2022-00090
• 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,Followup
• Report Date: 05/19/2023

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 Expiration Date: 03/31/2023
• Device Lot Number: ARSP008E
• 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; Not provided
• Supplement Dates FDA Received: 09/11/2022; 05/19/2023
• 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): Required Intervention
• Patient Sex: Male