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

Lot Number ARSP008E

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 05-jul-2022: this case involves a 61 years old male patient who had removed the water and injected cortizone in his left knee, water in the knee and knee hurt with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The causal role of drug cannot be excluded for the event.However, lack of information regarding event details, patient's compliance, treatment received, lab data and concomitant medications precludes the comprehensive assessment of the case.

Event Description

Removed the water and injected cortizone in his left knee [arthrocentesis], knee hurts [knee pain], water in the knee [joint effusion].Case narrative: initial information received on 05-jul-2022 regarding a solicited valid serious case received from the patient, 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 removed the water and injected cortizone in his left knee, water in the knee and knee hurt 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.On unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection 2ml 1x (3*2ml) (batch number: arsp008e) (expiry date: unknown, strength: 16mg/2ml) for osteoarthritis.On an unknown date after an unknown latency he occasionally gets a little water in his knees, especially in his left knee (joint effusion).When the patient went to the physician on tuesday, (b)(6) 2022 after a latency of 7 months 23 days he received synvisc injections in his right knee.The physician then removed the water and injected cortizone in his left knee (aspiration joint) and rescheduled his appointment to a later date for the left knee.He does not know when he gets the water only that his knee hurts (arthralgia).The last injection we have on file for his left knee was synvisc injections (3x2m1/lot #arsp008e) on friday, (b)(6) 2021.The last injection we have for his right knee was synvisc injections (3x2m1/lot #crsp002) on tuesday, (b)(6) 2022.It is unknown if there were lab data/results available action taken: not applicable.Cortizone corrective treatment was received for the event (aspiration joint) and not reported for other events.Outcome: not recovered / not resolved.Reporter causality: not reported for all the events.Company causality: not reportable for all the events.Based on the information received on 05-jul-2022.Case upgraded to serious from non-serious.Event of removed the water and injected cortizone in his left knee added.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment dated 29-jul-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].Removed the water and injected cortizone in his left knee [arthrocentesis].Knee hurts [knee pain].Water in the knee [joint effusion].Case narrative: initial information received on 05-jul-2022 regarding a solicited valid serious case received from the patient, 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 cases (b)(4) (multiple device), (b)(4) (multiple device) and (b)(4) (multiple device).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.At the time of the event, the patient had ongoing gonarthrosis with presence of calcium pyrophosphate.On unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection 2ml 1x (3 / 2ml) (batch number: arsp008e) (expiry date: unknown, strength: 16mg/2ml) for osteoarthritis.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, on (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]).Outcome: recovering.Reporter causality: not related for all the events.Company causality: not reportable for all the events.Additional information was received on 22-jul-2022 from the patient.Medical and event of synovitis was added.Text amended accordingly.

Event Description

Chronic synovitis on gonarthrosis (left knee) [synovitis chronic] removed the water and injected cortizone in his left knee [arthrocentesis] knee hurts [knee pain] water in the knee [joint effusion] case narrative: initial information received on 05-jul-2022 regarding a solicited valid serious case received from the patient, 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 is linked to cases (b)(4) (multiple device), (b)(4) (multiple device) and (b)(4) (multiple device).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.At the time of the event, the patient had ongoing gonarthrosis with presence of calcium pyrophosphate.On unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection 2ml 1x (3*2ml) (batch number: arsp008e) (expiry date: 31-mar-2023, strength: 16mg/2ml) for osteoarthritis.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 (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 for the event.Corrective treatment: hydrocortisone acetate (cortizone) for the event.Outcome: recovering for the event reporter causality: not related for all the events company causality: not reportable for all the events a product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc (lot/batch number: arsp008e) with global ptc number: (b)(4).The sample status of the ptc was not available.The production and quality control documentation for lot # 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 # batch record review & lot # frequency analysis for lot # arsp008e no capa is required.The final investigation was completed on (b)(6) 2022 with summarized conclusion as no assessment possible.Additional information was received on 22-jul-2022 from the patient.Medical and event of synovitis was added.Text amended accordingly.Additional information was received on 02-sep-2022 from other healthcare professional from quality department: ptc details were added.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2022: this this case involves a (b)(6) 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.

• 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: 15076769
• MDR Text Key: 296374128
• Report Number: 2246315-2022-00082
• 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: Study,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

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 Lot Number: ARSP008E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/03/2022; 09/11/2022
• 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
• Patient Sex: Male