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

Lot Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Ambulation Difficulties (2544)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6)2023 : this case involves an unknown age female patient who staph infection (staphylococcal infection), trouble walking, was using a walker (gait disturbance) after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc or synvisc one].Based on the available information regarding this case, causal role of the company suspect product was assessed as possible.Case will be re-evaluated post further update on the patient's underlying disease conditions, knee status at start of injections, injection technique used, concurrent knee disorders/injuries, post-injection routine followed by the patient and any other important risk factors, if any, for the reported events.

Event Description

Staph infection [staphylococcal infection nos] trouble walking, was using a walker and could barely walk [walking difficulty] arthritis [arthritis] ([knee swelling]) case narrative: initial information received on (b)(6)2023 regarding an unsolicited valid serious case (live follow up attached and both processed together) received from a patient from united states.This case involves an unknown age female patient who experienced staph infection, trouble walking, trouble walking, was using a walker and arthritis while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc or synvisc one].The patient's past medical history was reported as she was on osteo 5 years ago and ended up with a serious staph infection.Patient's other medical treatment(s), vaccination(s) and family history were not provided.On an unknown date in(b)(6)2023 , the patient started using hylan g-f 20, sodium hyaluronate injection (with unknown strength, dosage, frequency, route, batch number and expiry date) for product used for unknown indication.Patient stated that she received a synvisc injection in january 2023 (last month) and she has had swelling in her knee (joint swelling) and trouble walking (gait disturbance).She associated it with her arthritis and contacted her doctor who prescribed methotrexate.The methotrexate helped a little.Before she contacted her doctor, she was using a walker and could barely walk.Now she was able to walk but not very far.She stated she was on osteo 5 years ago and ended up with a serious staphylococcal infection and she wanted to make sure it was not something like that was going on (unknown latency for all events).Action taken: unknown for all the events.Corrective treatment: methotrexate for the event arthritis, walker for the event gait disturbance and not reported for other event.Outcome: recovering/resolving for the event arthritis and unknown for all other events.Seriousness criteria: disability for the gait disturbance and medically significant and intervention required for the event staphylococcal infection.

Event Description

Staph infection [staphylococcal infection nos].Trouble walking, was using a walker and could barely walk [walking difficulty].Arthritis [arthritis] ([knee swelling]).Case narrative: initial information received on 16-feb-2023 regarding an unsolicited valid serious case (live follow up attached and both processed together) received from a patient from united states.This case involves an unknown age female patient who experienced staph infection, trouble walking, trouble walking, was using a walker and arthritis while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc or synvisc one].The patient's past medical history was reported as she was on osteo 5 years ago and ended up with a serious staph infection and cancer.Patient's other medical treatment(s), vaccination(s) and family history were not provided.On an unknown date in (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection, strength: 48mg/6ml (with unknown dosage, frequency, route, batch number and expiry date) for product used for unknown indication.Patient stated that she received a synvisc injection in (b)(6) 2023 (last month) and she has had swelling in her knee (joint swelling) and trouble walking (gait disturbance).She associated it with her arthritis and contacted her doctor who prescribed methotrexate.The methotrexate helped a little.Before she contacted her doctor, she was using a walker and could barely walk.Now she was able to walk but not very far.She stated she was on osteo 5 years ago and ended up with a serious staphylococcal infection and she wanted to make sure it was not something like that was going on (unknown latency for all events).Consumer was feeling better and was just worried her body was rejecting the synvisc one due to past history of cancer.She did not have lot, expiration, or device for retrieval.Action taken: unknown for all the events.Corrective treatment: methotrexate for the event arthritis, walker for the event gait disturbance and not reported for other event.Outcome: recovering/resolving for the event arthritis and unknown for all other events.Seriousness criteria: disability for the gait disturbance and medically significant for the event staphylococcal infection.A product technical complaint (ptc) was initiated on 16-feb-2023 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Additional information was received on 16-feb-2023 from other healthcare professional (quality department).Global ptc number was added and strength was added.

Manufacturer Narrative

Sanofi company comment for follow up dated: 16-feb-2023 follow up information received does not change prior case assessment.This case involves an unknown age female patient who staph infection (staphylococcal infection), trouble walking, was using a walker (gait disturbance) after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc or synvisc one].Based on the available information regarding this case, causal role of the company suspect product was assessed as possible.Case will be re-evaluated post further update on the patient's underlying disease conditions, knee status at start of injections, injection technique used, concurrent knee disorders/injuries, post-injection routine followed by the patient and any other important risk factors, if any, for the reported events.

Event Description

Staph infection [staphylococcal infection nos] trouble walking, was using a walker and could barely walk [walking difficulty] arthritis [arthritis] ([knee swelling]).Case narrative: initial information received on 16-feb-2023 regarding an unsolicited valid serious case (live follow up attached and both processed together) received from a patient from united states.This case involves an unknown age female patient who experienced staph infection, trouble walking, trouble walking, was using a walker and arthritis while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc or synvisc one].The patient's past medical history was reported as she was on osteo 5 years ago and ended up with a serious staph infection.Patient's other medical treatment(s), vaccination(s) and family history were not provided.Patient has cancer.On an unknown date in (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution) strength: 48mg/6ml (with unknown dosage, frequency, route, batch number and expiry date) for product used for unknown indication.Patient stated that she received a synvisc injection in (b)(6) 2023 (last month) and she has had swelling in her knee (joint swelling) and trouble walking (gait disturbance).She associated it with her arthritis and contacted her doctor who prescribed methotrexate.The methotrexate helped a little.Before she contacted her doctor, she was using a walker and could barely walk.Now she was able to walk but not very far.She stated she was on osteo 5 years ago and ended up with a serious staphylococcal infection and she wanted to make sure it was not something like that was going on (unknown latency for all events).Consumer was feeling better and was just worried her body was rejecting the synvisc one due to past history of cancer.She did not have lot, expiration, or device for retrieval.Action taken: unknown for all the events.Corrective treatment: methotrexate for the event arthritis, walker for the event gait disturbance and not reported for other event.Outcome: recovering/resolving for the event arthritis and unknown for all other events.Seriousness criteria: disability for the gait disturbance and medically significant for the event staphylococcal infection.A product technical complaint (ptc) was initiated on 16-feb-2023 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.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."defect class had been updated to ii - (dp (b)(6) 2023).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 was identified and mitigated through the ncr (non conformance report) process.Sanofi will continue to monitor complaints and trending.Final investigation was completed on 16-mar-2023 with summarized conclusion provided as no assessment possible.Additional information was received on 16-feb-2023 from other healthcare professional (quality department).Global ptc number was added and strength was added.Additional information was received on 16-mar-2023 from quality department.The ptc results were added and 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: 16404539
• MDR Text Key: 309920088
• Report Number: 2246315-2023-00019
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• 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
• Patient Outcome(s): Other; Disability; Required Intervention
• Patient Sex: Female