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

Lot Number 8RSL029

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

Patient Problems Arthritis (1723); Bacterial Infection (1735); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 23-jan-2021: this case concerns a patient who was on treatment with synvisc one in left knee and had severe staph infection which required hospitalization and 2 clean out surgeries.The plausible causal role of the device cannot be denied, however, more information regarding patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications and other risk factors is required for further case assessment.

Event Description

Severe staph infection (left knee) [arthritis bacterial] ([staphylococcal infection]).Loss of cartilage and ultimately a loss of function and stability (left knee) [musculoskeletal disorder].Loss of cartilage and ultimately a loss of function and stability (left knee) [cartilage disorder].Loss of cartilage and ultimately a loss of function and stability (left knee) [joint instability].Case narrative: initial information received from united states on 15-jan-2021 from patient (significant) and healthcare professional (non-significant) regarding an unsolicited valid serious case.This case involves adult patient who experienced severe staph infection (left knee), loss of cartilage and ultimately a loss of function and stability (left knee), while he/she 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.Patient had purchased a number of hylan g-f 20, sodium hyaluronate injections to use overtime.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, injection in left knee (dose, frequency, route, indication, batch number: unknown).Information on the batch number was requested.On an unknown date in (b)(6) 2020 (last (b)(6)), patient had a severe staph infection (arthritis bacterial; staphylococcal infection) which resulted in hospitalization, 2 clean out surgeries, a loss of cartilage and ultimately a loss of function and stability (chondropathy, musculoskeletal disorder, joint instability).Patient had 5 unopened, still in the box hylan g-f 20, sodium hyaluronate products that patient was not comfortable using.Patient could not say for sure if the infection was from the product or from an error in the injection.Patient wanted to send the remaining 5 boxes back for a refund and to identify if there was an issue with the batch of the product.Event of arthritis bacterial and its symptom was assessed as serious due to hospitalization and required intervention and was medically significant.Action taken: not applicable for all events.Corrective treatment: clean out surgeries for arthritis bacterial, not reported for rest of the events.Outcome: unknown for all events.A product technical complaint was initiated on 15-jan-2021 for synvisc one for unknown batch number and global ptc number: (b)(4) and results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 09-feb-2021: this case concerns a patient who was on treatment with synvisc one in left knee and had severe staph infection which required hospitalization and clean out surgeries.The plausible causal role of the device cannot be excluded, however, more information regarding patient's clinical presentation, medical history, past drugs, concomitant medications and other risk factors is required for further case assessment.

Event Description

Severe staph infection (left knee) [arthritis bacterial] ([staphylococcal infection]) loss of cartilage and ultimately a loss of function and stability (left knee) [musculoskeletal disorder] loss of cartilage and ultimately a loss of function and stability (left knee) [cartilage disorder] loss of cartilage and ultimately a loss of function and stability (left knee) [joint instability] case narrative: initial information received from united states on 15-jan-2021 from patient (significant) and healthcare professional (non-significant) regarding an unsolicited valid serious case.This case involves adult patient who experienced severe staph infection (left knee), loss of cartilage and ultimately a loss of function and stability (left knee), while he/she 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.Patient had purchased a number of hylan g-f 20, sodium hyaluronate injections to use overtime.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, injection in left knee (dose, frequency, route, indication, batch number: unknown).Information on the batch number was requested.On an unknown date in (b)(6)-2020 (last (b)(6)), patient had a severe staph infection (arthritis bacterial; staphylococcal infection) which resulted in hospitalization, 2 clean out surgeries, a loss of cartilage and ultimately a loss of function and stability (chondropathy, musculoskeletal disorder, joint instability).Patient had 5 unopened, still in the box hylan g-f 20, sodium hyaluronate products that patient was not comfortable using.Patient could not say for sure if the infection was from the product or from an error in the injection.Patient wanted to send the remaining 5 boxes back for a refund and to identify if there was an issue with the batch of the product.Event of arthritis bacterial and its symptom was assessed as serious due to hospitalization and required intervention and was medically significant.Action taken: not applicable for all events corrective treatment: clean out surgeries for arthritis bacterial, not reported for rest of the events outcome: unknown for all events product technical complaint (ptc) was initiated with global ptc number 100096606 on 15-jan-2021 for product.Batch number; unknown device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance report) 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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required final investigation complete date: 09-feb-2021 follow up information from 02-feb-2021 from other healthcare professional.No significant information.Additional information was received on 09-feb-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.

Event Description

Severe staph infection (left knee) [arthritis bacterial] ([staphylococcal infection]).Loss of cartilage and ultimately a loss of function and stability (left knee) [musculoskeletal disorder].Loss of cartilage and ultimately a loss of function and stability (left knee) [cartilage disorder].Case narrative: initial information received from united states on 15-jan-2021 from patient (significant) and healthcare professional (non-significant) regarding an unsolicited valid serious case.This case involves adult patient who experienced severe staph infection (left knee), loss of cartilage and ultimately a loss of function and stability (left knee), while he/she 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.Patient had purchased a number of hylan g-f 20, sodium hyaluronate injections to use overtime.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, injection in left knee (dose, frequency, route, indication: unknown, batch number: 8rsl029, expiration: mar-2021).On an unknown date in (b)(6) 2020 (last (b)(6)), patient had a severe staph infection (arthritis bacterial; staphylococcal infection) which resulted in hospitalization, 2 clean out surgeries, a loss of cartilage and ultimately a loss of function and stability (chondropathy, musculoskeletal disorder, joint instability).Patient had 5 unopened, still in the box hylan g-f 20, sodium hyaluronate products that patient was not comfortable using.Patient could not say for sure if the infection was from the product or from an error in the injection.Patient wanted to send the remaining 5 boxes back for a refund and to identify if there was an issue with the batch of the product.Event of arthritis bacterial and its symptom was assessed as serious due to hospitalization and required intervention and was medically significant.Action taken: not applicable for all events.Corrective treatment: clean out surgeries for arthritis bacterial, not reported for rest of the events.Outcome: unknown for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 15-jan-2021 for product.Batch number: 8rsl029.Device not returned.The production and quality control documentation for lot 8rsl029, expiration date mar-2021 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl013b no capa (corrective and preventive action) is 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 has not indicated any safety issue.As of 23-mar-2021 there are 10 complaints on file for lot# 8rsl029 and all related sub-lots.8 complaints are on file for lot# 8rsl029a: (1) broken syringe tip and (7) adverse event reports.1 complaint is on file for lot# 8rsl029c: (1) leakage/llh.1 complaint is on file for lot# 8rsl029: (1) adverse event report.Sanofi would continue to monitor complaints as stated in sop (b)(4) product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: 29-mar-2021.Follow up information from 02-feb-2021 from other healthcare professional.No significant information.Additional information was received on 09-feb-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.Follow up received on 03-mar-2021 from healthcare professional.Complaint (b)(4) was re-opened due to incomplete information.No significant information received.Follow up was received on 06-mar-2021 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 19-mar-2021 from healthcare professional.Upon internal review batch number was added.Complaint number (b)(4) was cancelled as a duplicate.Text amended accordingly.Additional information received on 29-mar-2021 from healthcare professional.Global ptc results were updated.Text amended accordingly.

Event Description

Severe staph infection (left knee) [arthritis bacterial] ([staphylococcal infection]), loss of cartilage and ultimately a loss of function and stability (left knee), [musculoskeletal disorder].Loss of cartilage and ultimately a loss of function and stability (left knee) [cartilage disorder].Case narrative: initial information received from united states on 15-jan-2021 from patient (significant) and healthcare professional (non-significant) regarding an unsolicited valid serious case.This case involves adult patient who experienced severe staph infection (left knee), loss of cartilage and ultimately a loss of function and stability (left knee), while he/she 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.Patient had purchased a number of hylan g-f 20, sodium hyaluronate injections to use overtime.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, injection in left knee (dose, frequency, route, indication: unknown, batch number: 8rsl029, expiration: mar-2021).On an unknown date in (b)(6) 2020 (last may), patient had a severe staph infection (arthritis bacterial; staphylococcal infection) which resulted in hospitalization, 2 clean out surgeries, a loss of cartilage and ultimately a loss of function and stability (chondropathy, musculoskeletal disorder, joint instability).Patient had 5 unopened, still in the box hylan g-f 20, sodium hyaluronate products that patient was not comfortable using.Patient could not say for sure if the infection was from the product or from an error in the injection.Patient wanted to send the remaining 5 boxes back for a refund and to identify if there was an issue with the batch of the product.Event of arthritis bacterial and its symptom was assessed as serious due to hospitalization and required intervention and was medically significant.Action taken: not applicable for all events.Corrective treatment: clean out surgeries for arthritis bacterial, not reported for rest of the events.Outcome: unknown for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(6) on 15-jan-2021 for product.Batch number; unknown device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance report) 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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required final investigation complete date: 09-feb-2021.Follow up information from 02-feb-2021 from other healthcare professional.No significant information.Additional information was received on 09-feb-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.Follow up received on 03-mar-2021 from healthcare professional.Complaint (b)(4) was re-opened due to incomplete information.No significant information received.Follow up was received on 06-mar-2021 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 19-mar-2021 from healthcare professional.Upon internal review batch number was added.Complaint number (b)(4) was cancelled as a duplicate.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: 11224091
• MDR Text Key: 230946896
• Report Number: 2246315-2021-00033
• 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,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/01/2021
• Device Lot Number: 8RSL029
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention