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

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

Patient Problems Arthralgia (2355); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Knee is very swollen and painful [injection site joint swelling].Knee is very swollen and painful [injection site joint pain] body aches [general body pain].Case narrative: initial information received on (b)(6) 2021 from (b)(6) regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age female patient who experienced knee is very swollen and painful, knee is very swollen and painful and body aches 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 (dosage, frequency, route, lot unknown).On an unknown date, after unknown latency (less than a week), the patient had body aches (pain), knee was very swollen and painful (injection site joint pain, injection site joint swelling).These events of ), knee was very swollen and painful were leading to disability.Reportedly, the synvisc gave her nearly one year of relief but the week of her annual infiltration was pure hell.The patient had been able to get about home in a wheelchair but by day 7, she can get up to toilet in the night without assistance.The patient wondered if she could have an allergy.Action taken- unknown.Corrective treatment: wheelchair- knee is very swollen and painful, knee is very swollen and painful, not reported for body aches.At time of reporting, the outcome was not recovered / not resolved for the event body aches, was not recovered / not resolved for the event knee is very swollen and painful and was not recovered / not resolved for the event knee is very swollen and painful.

Event Description

Knee is very swollen and painful [injection site joint swelling].Knee is very swollen and painful [injection site joint pain].Body aches [general body pain].Case narrative: initial information received on 18-aug-2021 from canada regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age female patient who experienced very swollen and painful knee and body aches 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 (strength: 16 mg/ 2ml) (dosage, frequency, route, lot unknown).On an unknown date, after unknown latency (less than a week), the patient had body aches (pain), knee was very swollen and painful (injection site joint pain, injection site joint swelling).These events of knee was very swollen and painful were leading to disability.Reportedly, the synvisc gave her nearly one year of relief but the week of her annual infiltration was pure hell.The patient had been able to get about home in a wheelchair but by day 7, she can get up to toilet in the night without assistance.The patient wondered if she could have an allergy.Action taken- unknown.Corrective treatment: wheelchair- knee is very swollen and painful, knee is very swollen and painful, not reported for body aches.At time of reporting, the outcome was not recovered / not resolved for the event body aches, was not recovered / not resolved for the event knee is very swollen and painful and was not recovered / not resolved for the event knee is very swollen and painful.A product technical complaint (ptc) was initiated on 18-aug-2021 for synvisc.Batch number: unknown; comet compliant id number: (b)(4).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 is 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 has not indicated any safety issue.Final investigation complete date was 07-sep-2021.No safety issues were indicated in this review.Additional information was received on 07-sep-2021 from quality department.Global ptc number and ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12367047
• MDR Text Key: 268121779
• Report Number: 2246315-2021-00140
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability