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

Lot Number UNKNOWN

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

Patient Problems Pain (1994); Sepsis (2067); Discomfort (2330); Arthralgia (2355)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 30-jun-2020: the case involves female patient who had treatment with synvisc one in right knee and it could be septic.The information in the case is very limited and there is no evidence of the event to occur with device.However, it was reported that healthcare professional may have injected the synvisc-one in a vein which could be explain the occurrence of event.Further, detailed information regarding other medications, medical history would aid in comprehensive assessment of the case.

Event Description

Could be septic [septic joint] ([incorrect route of product administration], [discomfort in joints], [leg pain], [aching (r) knee]).Can't hardly walk now [walking difficulty].Case narrative: initial information received from united states on 25-jun-2020 regarding an unsolicited valid serious case received from patient.This case involves a (b)(6) female patient who, was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and could be septic and cant hardly walk now.The patient's past medical history, vaccination(s) and family history were not provided.It was reported that patient was treated with hylan g-f 20, sodium hyaluronate for past 5 years and it always worked for her for the torn meniscus and arthritis.At the time of report, patient had bone on bone.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml, once via unknown route (lot - unknown) for torn meniscus and arthritis.Information on batch number was requested.At the time of injection her healthcare professional told her that she needed a partial knee replacement on the inner right side because it is bone on bone.The patient states that her previous healthcare professional (hcp) would have her lay down, mark the spot and then inject the hylan g-f 20, sodium hyaluronate, however this hcp just had her sit there and injected her without marking her.The patient complained of her knee hurting on one side, it feels like a brick on top of her knee cap.Patient felt pain up the back of her leg into her thigh and she cant hardly walk now (onset and latency: unknown).The patient called the hcp and talked to a nurse who stated that the hcp may have injected the hylan g-f 20, sodium hyaluronate in a vein and it could be septic (medically significant).The nurse offered to give the patient a prescription of tramadol for the pain.The patient was going to make an appointment to see the hcp so they can take a look at her knee, diagnose and treat it from there.Action taken: not applicable for both events.Corrective treatment: tramadol for could be septic, not reported for cant hardly walk now.Outcome: unknown for both events.A product technical complaint was initiated and results were pending for the same.

Event Description

Could be septic [septic joint] ([incorrect route of product administration], [discomfort in joints], [leg pain], [aching (r) knee]).Cant hardly walk now [walking difficulty].Case narrative: initial information received from united states on 25-jun-2020 regarding an unsolicited valid serious case received from patient.This case involves a 63 years old female patient who, was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and could be septic and cant hardly walk now.The patient's past medical history, vaccination(s) and family history were not provided.It was reported that patient was treated with hylan g-f 20, sodium hyaluronate for past 5 years and it always worked for her for the torn meniscus and arthritis.At the time of report, patient had bone on bone.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml, once via unknown route (lot - unknown) for torn meniscus and arthritis.Information on batch number was requested.At the time of injection her healthcare professional told her that she needed a partial knee replacement on the inner right side because it is bone on bone.The patient states that her previous healthcare professional (hcp) would have her lay down, mark the spot and then inject the hylan g-f 20, sodium hyaluronate, however this hcp just had her sit there and injected her without marking her.The patient complained of her knee hurting on one side, it feels like a brick on top of her knee cap.Patient felt pain up the back of her leg into her thigh and she cant hardly walk now (onset and latency: unknown).The patient called the hcp and talked to a nurse who stated that the hcp may have injected the hylan g-f 20, sodium hyaluronate in a vein and it could be septic (medically significant).The nurse offered to give the patient a prescription of tramadol for the pain.The patient was going to make an appointment to see the hcp so they can take a look at her knee, diagnose and treat it from there.Action taken: not applicable for both events.Corrective treatment: tramadol for could be septic, not reported for cant hardly walk now.Outcome: unknown for both events.Product technical complaint (ptc) was initiated with global ptc number 100049748 on 26-jun-2020 for product.Batch number; unknown.Device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa 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 process.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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required final investigation complete date: 30-jun-2020.Follow up received on 25-jun-2020 from other healthcare professional.Global ptc number added.Additional information was received on 30-jun-2020 from healthcare professional.Global ptc results added.Text was amended accordingly.

Manufacturer Narrative

Sanofi company comment dated 30-jun-2020: the case involves female patient who had treatment with synvisc one in right knee and it could be septic.The information in the case is very limited and there is no evidence of the event to occur with device.However, it was reported that healthcare professional may have injected the synvisc-one in a vein which could be explain the occurrence of event.Further, detailed information regarding other medications, medical history would aid in comprehensive assessment of the case.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10223465
• MDR Text Key: 201251381
• Report Number: 2246315-2020-00075
• 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
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention