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

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

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Type  Injury  

Event Description

Developed very large effusion, right knee [effusion (r) knee] case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from physician via health authorities of united states under reference mw5097802.This case involves an adult patient who experienced developed very large effusion, right knee, after 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 in right knee each one week apart (dosage, indication, lot number unknown).The information regarding lot number cannot be requested.On an unknown date, 1 week after the last injection, the patient developed very large effusion, right knee (joint effusion).This event was assessed as medically significant.Action taken- not applicable it was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for developed very large effusion, right knee.A product technical complaint (ptc) was initiated and results were pending for the same with (b)(4).Follow up information was received on 14-dec-2020 from the healthcare professional.The information from duplicate case (b)(4) was merged into this case.Global ptc number added.No significant information was received.

Event Description

Developed very large effusion, right knee [effusion (r) knee].Case narrative: this case is linked to case (b)(4) (duplicate).Initial information was received on 14-dec-2020 regarding an unsolicited valid serious case from physician via health authorities of united states under reference mw5097802.This case involves an adult patient who developed very large effusion, right knee, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, injection in right knee, each one week apart via intra-articular route (dose, indication, and lot number: unknown).The information regarding lot number cannot be requested.On an unknown date, 1 week after the last injection, the patient developed very large effusion, right knee (joint effusion).This event was assessed as medically significant.Action taken- not applicable it was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for developed very large effusion, right knee.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc, batch number: unknown; gptc number (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.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 ncr (non-conformance) 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.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa is required.Final investigation was completed on 23-dec-2020.Follow up information was received on 14-dec-2020 from the healthcare professional.The information from duplicate case (b)(4) was merged into this case.Global ptc number added.No significant information was received.Additional information was received on 23-dec-2020 from other healthcare professional: ptc results were received and added to the case.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11053267
• MDR Text Key: 227548706
• Report Number: 2246315-2020-00174
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention