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

Lot Number UNKNOWN

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

Patient Problem Pulmonary Embolism (1498)

Event Date 01/01/2011

Event Type  Injury  

Event Description

Pulmonary embolism that started in right leg [pulmonary embolism] ([device ineffective], [embolus leg]).Case narrative: initial information from unites states received on 08-apr-2021 regarding an unsolicited valid serious case received from the patient.This case involves adult patient who experienced pulmonary embolism that started in right leg, while he/she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included severe left knee injury while re-roofing our community hall roof in 1970, removal of the meniscus in 1970.Patient was given rooster comb extract to mend or repair cartilage that worked like a miracle for more than ten years.The patient's past, vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (form, strength, dose, frequency, route, lot number, indication: unknown) in right knee.Information regarding batch number requested.Patient was informed that hylan g-f 20, sodium hyaluronate now used bacteria to produce the fluid and it did not work this time (device ineffective).On an unknown date in 2011, after unknown latency developed a pulmonary embolism that started in right leg (pulmonary embolism and peripheral embolism) but that was all over and no longer took any blood thinners (certainly not warfarin) except 100mg of aspirin.The event was medically significant.Patient wanted advice as both knees were giving lot of pain supposedly due to osteoarthritis.Action taken: unknown.The patient was treated with warfarin and acetylsalicylic acid (aspirin 81) for pulmonary embolism.The patient outcome is reported as recovered / resolved on an unknown date for pulmonary embolism.A product technical complaint was initiated and the results for the same were pending.

Event Description

Pulmonary embolism that started in right leg [pulmonary embolism] ([device ineffective], [embolus leg]).Case narrative: initial information from unites states received on 08-apr-2021 regarding an unsolicited valid serious case received from the patient.This case involves adult patient who experienced pulmonary embolism that started in right leg, while he/she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included severe left knee injury while re-roofing our community hall roof in 1970, removal of the meniscus in 1970.Patient was given rooster comb extract to mend or repair cartilage that worked like a miracle for more than ten years.The patient's past, vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (form, strength, dose, frequency, route, lot number, indication: unknown) in right knee.Information regarding batch number requested.Patient was informed that hylan g-f 20, sodium hyaluronate now used bacteria to produce the fluid and it did not work this time (device ineffective).On an unknown date in 2011, after unknown latency developed a pulmonary embolism that started in right leg (pulmonary embolism and peripheral embolism) but that was all over and no longer took any blood thinners (certainly not warfarin) except 100mg of aspirin.The event was medically significant.Patient wanted advice as both knees were giving lot of pain supposedly due to osteoarthritis.Action taken: unknown.The patient was treated with warfarin and acetylsalicylic acid (aspirin 81) for pulmonary embolism.The patient outcome is reported as recovered / resolved on an unknown date for pulmonary embolism.A product technical complaint (ptc) was initiated on 08-apr-2021 for synvisc, batch number: unknown with global ptc 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 was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed 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 was completed on 26-apr-2021.Additional information was received on 26-apr-2021 from other health care professional.Global ptc number and results were added.Text was amended accordingly.

Event Description

Pulmonary embolism that started in right leg [pulmonary embolism] ([device ineffective], [embolus leg]) 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 from unites states received on 08-apr-2021 regarding an unsolicited valid serious case received from the patient.This case involves adult patient who experienced pulmonary embolism that started in right leg, while he/she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included severe left knee injury while re-roofing our community hall roof in 1970, removal of the meniscus in 1970.Patient was given rooster comb extract to mend or repair cartilage that worked like a miracle for more than ten years.The patient's past, vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (form, strength, dose, frequency, route, lot number, indication: unknown) in right knee.Information regarding batch number requested.Patient was informed that hylan g-f 20, sodium hyaluronate now used bacteria to produce the fluid and it did not work this time (device ineffective).On an unknown date in 2011, after unknown latency developed a pulmonary embolism that started in right leg (pulmonary embolism and peripheral embolism) but that was all over and no longer took any blood thinners (certainly not warfarin) except 100mg of aspirin.The event was medically significant.Patient wanted advice as both knees were giving lot of pain supposedly due to osteoarthritis.Action taken: unknown.The patient was treated with warfarin and acetylsalicylic acid (aspirin 81) for pulmonary embolism.The patient outcome is reported as recovered / resolved on an unknown date for pulmonary embolism.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc, batch number: unknown with global ptc 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 was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed 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 was completed on (b)(6) 2021.Additional information was received on (b)(6) 2021 from other health care professional.Global ptc number and results were added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11671984
• MDR Text Key: 262865773
• Report Number: 2246315-2021-00091
• 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,Followup
• Report Date: 06/11/2021

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: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/30/2021; 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention