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

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

Patient Problem Arthritis (1723)

Event Date 09/15/2018

Event Type  Injury  

Event Description

Pseudoseptic reaction in knee [pseudosepsis] ([knee pain], [knee swelling], [difficulty in walking]).Case narrative: initial information regarding this unsolicited valid serious case from united states was received on 05-feb-2021 from the health professional.This case is linked to case (b)(4) (same patient).This case involves an adult male patient who experienced pseudoseptic reaction in knee, while he was treated with medical device hylan g f 20 (synvisc).The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient started taking hylan g f 20 injection at a dose of one time injection in both knees via intra-articular route (with an unknown strength, lot/batch number and indication).There will be no information available on the batch number of this case.On (b)(6) 2018, after an unknown latency, the patient developed a pseudoseptic reaction in knee (pseudosepsis) where he was instructed to rest the knees as much as possible, had severe difficulty walking for weeks (gait disturbance), swelling (joint swelling) and pain (arthralgia).Action taken: unknown.It was not reported if the patient received a corrective treatment.The outcome was reported as unknown for the event.Seriousness criteria: the event was leading to disability.A product technical complaint (ptc) was initiated on (b)(6) 2021 for hylan g f 20 (synvisc); batch number: unknown; global ptc number: 100100959.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 (b)(4) "product event handling" to determine if a capa is required.Final investigation was completed on (b)(6) 2021.Additional information was received on 12-feb-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

Event Description

Pseudoseptic reaction in knee [pseudosepsis] ([knee pain], [knee swelling], [difficulty in walking]).Case narrative: this case is deleted following an incorrect worldwide id.The new case (b)(4) will be submitted with the same information.Initial information regarding this unsolicited valid serious case from united states was received on 05-feb-2021 from the health professional.This case is linked to case (b)(4) (same patient).This case involves an adult male patient who experienced pseudoseptic reaction in knee, while he was treated with medical device hylan g f 20 (synvisc).The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient started taking hylan g f 20 injection at a dose of one time injection in both knees via intra-articular route (with an unknown strength, lot/batch number and indication).There will be no information available on the batch number of this case.On (b)(6) 2018, after an unknown latency, the patient developed a pseudoseptic reaction in knee (pseudosepsis) where he was instructed to rest the knees as much as possible, had severe difficulty walking for weeks (gait disturbance), swelling (joint swelling) and pain (arthralgia).Action taken: unknown.It was not reported if the patient received a corrective treatment.The outcome was reported as unknown for the event.Seriousness criteria: the event was leading to disability.A product technical complaint (ptc) was initiated on 04-feb-2021 for hylan g f 20 (synvisc); batch number: unknown; global ptc 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 12-feb-2021.Additional information was received on 12-feb-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.Follow up information was received on 24-mar-2021 from the other healthcare professional.Investigation with (b)(4) was reopened due to incomplete compliant information.No significant information added.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11357898
• MDR Text Key: 242212749
• Report Number: 2246315-2021-00076
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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): Required Intervention; Disability