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

Lot Number ARSP013

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Ambulation Difficulties (2544)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Allergic reaction [device allergy] ([injection site joint swelling], [condition aggravated], [blue skin], [fever], [injection site joint pain], [difficulty in walking]).Case narrative: this case is linked to (b)(4) (multiple devices, first injection).Initial information was received from united states on 18-feb-2022 regarding an unsolicited valid serious case from a patient.This case involves a (b)(6) female patient who experienced allergic reaction with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc] (second injection).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.She states she had synvisc 12 years ago with no trouble.The patient had first injection of synvisc series on (b)(6) 2021.On (b)(6) 2022, the patient received second injection of synvisc (hylan g-f 20, sodium hyaluronate) for osteoarthritis (lot - arsp013, expiration date: 30-apr-2023).On an unknown date in 2022, after unknown latency, after this injection she found it very difficult to walk (gait disturbance) and had swelling triple the size of normal (injection site joint swelling, condition aggravated).Her leg below her knee was discolored, mottled bluish (cyanosis).She had a fever 101.2 degrees f (pyrexia).She states the pain was incredible (injection site joint pain) and would scream out for a couple of days after the injection.She had to use a cane to ambulate.She was given a medrol dose pack which was effective at reducing swelling, pain, and fever.She did not have a third injection.Hcp (healthcare professional) told her she had an allergic reaction (device allergy, caused disability, required intervention), not an adverse event.Action taken: drug withdrawn.Corrective treatment: methylprednisolone (medrol dosepak) and cane to ambulate.At time of reporting, the outcome was unknown for the event allergic reaction.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 01-mar-2022: this case involves a (b)(6) female patient who experienced allergic reaction after treated with hylan g-f 20, sodium hyaluronate [synvisc] (second injection).Based on the available information, causal relationship between the event and suspect product was assessed as reportable/possible due to the feasible temporal gap for the occurrence of events.However, case would be re-assessed when further information regarding patient¿s past medications, concomitant medications, allergic history, ptc (product technical complaint) results, concurrent clinical presentations, and other risk factors becomes available.

Manufacturer Narrative

Sanofi company comment dated 01-mar-2022: this case involves a 66 years old female patient who experienced allergic reaction after treated with hylan g-f 20, sodium hyaluronate [synvisc] (second injection).Based on the available information, causal relationship between the event and suspect product was assessed as reportable/possible due to the feasible temporal gap for the occurrence of events.However, case would be re-assessed when further information regarding patient¿s past medications, concomitant medications, allergic history, ptc (product technical complaint) results, concurrent clinical presentations, and other risk factors becomes available.

Event Description

Allergic reaction [device allergy] ([injection site joint swelling], [condition aggravated], [blue skin], [fever], [injection site joint pain], [difficulty in walking]).Case narrative: this case is linked to 2022sa058053 (multiple devices, first injection).Initial information was received from united states on 18-feb-2022 regarding an unsolicited valid serious case from a patient.This case involves a 66 years old female patient who experienced allergic reaction with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc] (second injection).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.She states she had synvisc 12 years ago with no trouble.The patient had first injection of synvisc series on (b)(6) 2021.On (b)(6) 2022, the patient received second injection of synvisc (hylan g-f 20, sodium hyaluronate) for osteoarthritis (lot - arsp013, expiration date: 30-apr-2023).On an unknown date in 2022, after unknown latency, after this injection she found it very difficult to walk (gait disturbance) and had swelling triple the size of normal (injection site joint swelling, condition aggravated).Her leg below her knee was discolored, mottled bluish (cyanosis).She had a fever 101.2 degrees f (pyrexia).She states the pain was incredible (injection site joint pain) and would scream out for a couple of days after the injection.She had to use a cane to ambulate.She was given a medrol dose pack which was effective at reducing swelling, pain, and fever.She did not have a third injection.Hcp (healthcare professional) told her she had an allergic reaction (device allergy, caused disability, required intervention), not an adverse event.Action taken: drug withdrawn.Corrective treatment: methylprednisolone (medrol dosepak) and cane to ambulate.At time of reporting, the outcome was unknown for the event allergic reaction.A product technical complaint (ptc) was initiated, and the results were pending for the same.Additional information was received on 27-jul-2022 from the other healthcare professional.Collection organization was updated.Text amended accordingly.Local comments: *downgrade*.

Event Description

Allergic reaction [device allergy] ([injection site joint swelling], [condition aggravated], [skin discoloration], [fever], [injection site joint pain], [difficulty in walking]).Case narrative: this case is linked to (b)(4) (multiple device suspect used for the same patient, first synvisc injection).Initial information was received from united states on 18-feb-2022 regarding an unsolicited valid serious case from a patient.This case involves a 66 years old female patient who experienced allergic reaction with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc] (second injection).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.She states she had synvisc 12 years ago with no trouble.The patient had first injection of synvisc series on (b)(6) 2021.On 05-jan-2022, the patient received second injection of synvisc (hylan g-f 20, sodium hyaluronate), (liquid solution), strength 16 mg/2ml (at unknown dose, route, frequency) (lot - arsp013, expiration date: 30-apr-2023) for osteoarthritis.On an unknown date in 2022, after unknown latency, after this injection she found it very difficult to walk (gait disturbance) and had swelling triple the size of normal (injection site joint swelling, condition aggravated).Her leg below her knee was discolored, mottled bluish (skin discoloration).She had a fever 101.2 degrees f (pyrexia).She states the pain was incredible (injection site joint pain) and would scream out for a couple of days after the injection.She had to use a cane to ambulate.She was given a medrol dose pack which was effective at reducing swelling, pain, and fever.She did not have a third injection.Hcp (healthcare professional) told her she had an allergic reaction (device allergy, caused disability, required intervention), not an adverse event.Relevant laboratory test results included: body temperature - in 2022: 101.2 f.Action taken: drug withdrawn.Corrective treatment: methylprednisolone (medrol dosepak) and cane to ambulate.At time of reporting, the outcome was unknown for the event allergic reaction.A product technical complaint (ptc) was initiated on 18-feb-2022 for synvisc (batch number : arsp013 and expiry date: 30-apr-2023) with global ptc number: (b)(4).Sample status of ptc was not available, and ptc stated based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.(tj 20jun2023).Batch # arsp013, synvisc was manufactured on 13may2020 with expiration date of 30apr2023 yielding (b)(4) kits the incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.It was the requirement to review all finished batch records for specification conformance prior to release.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Based on investigation and trend analysis, no capa required.There was no quality related defect that would attribute to a malfunction, death, or serious injury.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis to determine if a capa (corrective and preventive actions )was required.The final investigation was completed on 20-jun-2023 with summarized conclusion as no assessment possible additional information was received on 27-jul-2022 from the other healthcare professional.Collection organization was updated.Text amended accordingly.Follow up information was received on 18-feb-2022 (captured in general tab as 27-jul-2022 to avoid e2b negative acknowledgment.)from other healthcare professional via quality department.Strength added.Ptc number added.Text amended accordingly.Follow up information was received on 20-jun-2023 from other healthcare professional via quality department.Ptc complete details added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• 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: 13633403
• MDR Text Key: 291312902
• Report Number: 2246315-2022-00020
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Lot Number: ARSP013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: MEDROL DOSEPAK (METHYLPREDNISOLONE),UNKNOWN
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female