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 Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Effect of angry knee (swollen, hot, warm to touch, infection) [joint infection].Effect of angry knee (swollen, hot, warm to touch, infection) [joint warmth].Effect of angry knee (swollen, hot, warm to touch, infection) [knee swelling].Case narrative: initial information received on (b)(6) 2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves adult and unknown gender patient who experienced effect of angry knee (swollen, hot, warm to touch, infection) 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 an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, (formulation, batch number, indication, frequency, frequency: unknown).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced effect of angry knee (swollen, hot, warm to touch, infection) (arthritis infective) (joint warmth) (joint swelling).There were 20 kits that the facility has in their possession, not 22.Action taken: unknown.It was not reported if the patient received a corrective treatment for the events (effect of angry knee (swollen, hot, warm to touch, infection).Outcome: unknown for all the events.

Event Description

Effect of angry knee (swollen, hot, warm to touch, infection) [joint infection].Effect of angry knee (swollen, hot, warm to touch, infection) [joint warmth].Effect of angry knee (swollen, hot, warm to touch, infection) [knee swelling].Case narrative: initial information received on 28-jan-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional).This case involves adult and unknown gender patient who had effect of angry knee (swollen, hot, warm to touch, infection) 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 an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, via intra-articular route (batch number, indication, dose, frequency: unknown; strength: 16 mg/2 ml).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced effect of angry knee (swollen, hot, warm to touch, infection) (arthritis infective) (joint warmth) (joint swelling).There were 20 kits that the facility has in their possession, not 22.Action taken: unknown for all events.It was not reported if the patient received a corrective treatment for the events (effect of angry knee (swollen, hot, warm to touch, infection).Outcome: unknown for all the events.A product technical complaint (ptc) was initiated on 28-jun-2022 for synvisc one (unknown batch number) with global ptc number: (b)(4).Sample status was not available.The final investigation was in process.Additional information received on 27-jul-2022 from patient via health authority.The collecting organization updated.Text amended accordingly.Additional information was received on 28-jun-2022 (actual csd is on 28-jun-2022, taken as 06-jun-2023 to avoid negative acknowledgment) from other health care professional.Global ptc number and strength was added.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment for follow dated 28-jun-2022: follow up information received does not change prior case assessment.This case involves adult and unknown gender patient who had effect of angry knee (swollen, hot, warm to touch, infection) with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the limited information provided regarding this case, causal role of the company suspect product i.E.Hylan g-f 20, sodium hyaluronate in causing the events cannot be denied.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Manufacturer Narrative

Sanofi company comment for follow dated 16-jun-2023: follow up information received does not change prior case assessment.This case involves adult and unknown gender patient who had effect of angry knee (swollen, hot, warm to touch, infection) with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the limited information provided regarding this case, causal role of the company suspect product i.E.Hylan g-f 20, sodium hyaluronate in causing the events cannot be denied.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Effect of angry knee (swollen, hot, warm to touch, infection) [joint infection] effect of angry knee (swollen, hot, warm to touch, infection) [joint warmth] effect of angry knee (swollen, hot, warm to touch, infection) [knee swelling] case narrative: initial information received on 28-jan-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional).This case involves adult and unknown gender patient who had effect of angry knee (swollen, hot, warm to touch, infection) 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 an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, via intra-articular route (batch number, indication, dose, frequency: unknown; strength: 16 mg/2 ml).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced effect of angry knee (swollen, hot, warm to touch, infection) (arthritis infective) (joint warmth) (joint swelling).There were 20 kits that the facility has in their possession, not 22.Action taken: unknown for all events it was not reported if the patient received a corrective treatment for the events (effect of angry knee (swollen, hot, warm to touch, infection).Outcome: unknown for all the events.A product technical complaint (ptc) was initiated on 28-jun-2022 for synvisc (unknown batch number) with global ptc number 100334190.The sample status was not available and ptc stated: based on the complaint from intake team, there is 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.Investigation (tj 15jun2023) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 16-jun-2023 with summarized conclusion as no assessment possible.Additional information received on 27-jul-2022 from patient via health authority.The collecting organization updated.Text amended accordingly.Additional information was received on 28-jun-2022 (actual csd is 28-jun-2022, taken as 06-jun-2023 to avoid negative acknowledgment) from other health care professional.Global ptc number and strength was added.Text amended accordingly.Additional information was received on 16-jun-2023 from quality department: ptc details with summarized conclusion added.Text was 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: 13479891
• MDR Text Key: 285244006
• Report Number: 2246315-2022-00013
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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; Other