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

Lot Number 9RSL036B

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

Patient Problems Bacterial Infection (1735); Erythema (1840); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 08/06/2020

Event Type  Injury  

Event Description

Pseudosepsis [pseudosepsis] ([joint warmth], [aching (r) knee], [localized erythema], [swelling of r knee], [effusion (r) knee], [synovial fluid culture positive], [staphylococcus test positive]).Case narrative: the case is linked to (b)(4) (cluster).Initial information received on 14-aug-2020 regarding an unsolicited valid serious case received from other healthcare professional via call center from united states.This case involves a (b)(6) years old male patient who experienced pseudosepsis, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate solution for injection in right knee (prior to which effusion was removed from right knee) at dose of 48 mg once via unknown route (batch number - 9rsl036b; expiration date: unknown) for oa (osteoarthritis).On (b)(6) 2020, three days after administration of hylan g-f 20, sodium hyaluronate, patient reported severe heat, pain, redness and swelling (right knee).On an unknown date in (b)(6) 2020, after latency of few days healthcare professional removed effusion and sent for culture and results were staph (staphylococcus) and gram positive cocci.Patient was hospitalized for the same (unknown date (b)(6) 2020).Then, arthroscopic irrigation and drainage were performed and patient was administered iv (intravenous) antibiotics(unspecified).It was unknown if patient remained in hospital.No more information provided.Action taken: not applicable.Corrective treatment: arthroscopic irrigation, drainage performed and administered iv antibiotics.Outcome: unknown.A product technical complaint was initiated and results were pending for the same.

Event Description

Pseudosepsis [pseudosepsis] ([joint warmth], [aching (r) knee], [localized erythema], [swelling of r knee], [effusion (r) knee], [synovial fluid culture positive], [staphylococcus test positive]) case narrative: the case is linked to (b)(4) (cluster) initial information received on 14-aug-2020 regarding an unsolicited valid serious case received from other healthcare professional via call center from united states.This case involves a 62 years old male patient who experienced pseudosepsis, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On 03-aug-2020, the patient received treatment with hylan g-f 20, sodium hyaluronate solution for injection in right knee (prior to which effusion was removed from right knee) at dose of 48 mg once via unknown route (batch number - 9rsl036b; expiration date: 31-aug-2022) for oa (osteoarthritis).On 06-aug-2020, three days after administration of hylan g-f 20, sodium hyaluronate, patient reported severe heat, pain, redness and swelling (right knee).On an unknown date in aug-2020, after latency of few days healthcare professional removed effusion and sent for culture and results were staph (staphylococcus) and gram positive cocci.Patient was hospitalized for the same (unknown date aug-2020).Then, arthroscopic irrigation and drainage were performed and patient was administered iv (intravenous) antibiotics(unspecified).It was unknown if patient remained in hospital.No more information provided.Action taken: not applicable corrective treatment: arthroscopic irrigation, drainage performed and administered iv antibiotics outcome: unknown a product technical complaint (ptc) was initiated on 14-aug-2020 for synvisc one (lot number 9rsl036b)and with global ptc number 100060462.The production and quality control documentation for lot # 9rsl036b expiration date (2022-08) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot #9rsl036b no capa was required.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.As of 20aug2020 there is 1 complaint on file for lot# 9rsl036 and all related sublots.1 complaint was on file for lot# 9rsl036b: (1) adverse event report.Sanofi would continue to monitor complaints as stated in to determine if a capa was required.Final investigation was completed on 20-aug-2020.Follow up information was received on 14-aug-2020 from other health professional.Global ptc number was added.No significant information was received.Additional information was received on 20-aug-2020 from a healthcare professional.Global ptc number was updated.Ptc results received and processed.

Event Description

Knee pyogenic arthritis [arthritis infective] ([staphylococcus test positive], [joint warmth], [aching (r) knee], [localized erythema], [swelling of r knee], [effusion (r) knee], [synovial fluid culture positive], [pseudosepsis], [edema lower limb]).Case narrative: this case was linked to cases (b)(4) (cluster).Initial information received on (b)(6) 2020 from united states regarding an unsolicited valid serious case received from other health professional.This case involves a 62 years old male patient (179.8 cm and 188 kg) who experienced knee pyogenic arthritis, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of event, patient had ongoing diabetes.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection in right knee (prior to which effusion was removed from right knee) at dose of 6ml once via intra-articular route (batch number - 9rsl036b; expiration date: (b)(6) 2022) for oa (osteoarthritis).On (b)(6) 2020, after 2 days, patient developed knee pyogenic arthritis (arthritis infective) (life threatening, hospitalization, intervention required and medically significant), edema lower extremities, knee joint effusion and knee pain.On (b)(6) 2020, after latency of few days hcp (healthcare professional) removed effusion and sent for culture and results were staph (staphylococcus) and gram positive cocci.Patient was hospitalized and underwent surgery.Then, arthroscopic irrigation and drainage were performed and patient was administered iv (intravenous) antibiotics(unspecified).On (b)(6) 2020, 3 days after administration of hylan g-f 20, sodium hyaluronate, patient reported severe heat, pain, redness and swelling (right knee).On (b)(6) 2020, patient recovered from knee pyogenic arthritis.Action taken: not applicable.Corrective treatment: arthroscopic irrigation, drainage performed, surgery and administered iv antibiotics.Outcome: recovered/resolved.A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one (lot number 9rsl036b) and with global ptc number 100060462.The production and quality control documentation for lot # 9rsl036b expiration date (aug-2022) was reviewed.The investigation showed that the product met specifications.No associated non conformance's were noted.Based on the lot # batch record review & lot # frequency analysis for lot #9rsl036b no capa was required.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.As of 20aug2020 there is 1 complaint on file for lot# 9rsl036 and all related sublots.1 complaint was on file for lot# 9rsl036b: (1) adverse event report.Sanofi would continue to monitor complaints as stated in to determine if a capa was required.Final investigation was completed on 20-aug-2020.Follow up information was received on 14-aug-2020 from other health professional.Global ptc number was added.No significant information was received.Additional information was received on 20-aug-2020 from a healthcare professional.Global ptc number was updated.Ptc results received and processed.Additional information received on 10-sep-2020 from other healthcare professional.History of diabetes added.Event of knee pyogenic arthritis (arthritis infective) and edema lower extremities added.Seriousness criterion of life threatening added.Event start and stop dates updated.Event outcome updated.Verbatim updated to hcp removed effusion/knee joint effusion.Corrective treatment added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10419531
• MDR Text Key: 209402091
• Report Number: 2246315-2020-00097
• 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,Followup
• Report Date: 09/17/2020

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 Expiration Date: 08/31/2022
• Device Lot Number: 9RSL036B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/26/2020; 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 188