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

Lot Number 9RSL043

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

Patient Problems Inflammation (1932); Joint Disorder (2373)

Event Date 08/12/2020

Event Type  Injury  

Event Description

Pseudosepsis (left knee) [pseudosepsis], knee pain (left knee) [injection site joint pain], knee joint effusion (left knee) [injection site joint effusion].Case narrative: based on additional information received on 10-sep-2020 from other healthcare professional (orthopedic technician), this case initially processed as non-serious was upgraded to serious as event of pseudosepsis was updated to serious with criteria of life threatening, medically significant, hospitalisation and required surgical intervention (because its newly added symptoms- knee pain, and knee joint effusion were assessed as serious).This case is linked to case (b)(4) (cluster) (same patient, multiple devices, right knee).Initial information from united states received on 14-aug-2020 regarding an unsolicited valid serious case from other health professional.This case involves a (b)(6) years old male patient (182.8 cm and 100.24 kg) who experienced pseudosepsis (left knee), after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) in left knee.The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection (synvisc one) (strength: 48 mg/ 6 ml, syringe) in left knee at the dose of 6 ml (48 mg) once (one use, one dose) via intra-articular route for oa (osteoarthritis)(lot - 9rsl043; expiration date: unknown).On same day after the injection, the patient had pseudosepsis, knee pain (injection site joint pain), knee joint effusion (injection site joint effusion) in left knee.The events of pseudosepsis, knee pain, and knee joint effusion were assessed serious due to being considered as life threatening, medically significant, required hospitalisation and surgical intervention.The patient was hospitalised on (b)(6) 2020 and on same day had surgery on left knee to have left knee chondroplasty, incision and drainage.On (b)(6) 2020, the patient was discharged and recovered from knee pain and knee joint effusion.Reportedly, the patient was hospitalised for only 1 day.Action taken: not applicable.Corrective treatment: left knee chondroplasty, incision and drainage.The patient outcome is reported as unknown.A product technical complaint (ptc) was initiated and the results for the same were pending.Additional information was received on 10-sep-2020 from other healthcare professional (orthopedic technician).Symptoms knee pain, and knee joint effusion were added for pseudosepsis.Event of pseudosepsis was upgraded to serious and overall case seriousness was also updated.Suspect details were updated.Clinical course was updated.Text was amended accordingly.

Event Description

Pseudosepsis (left knee) [pseudosepsis].Knee pain (left knee) [injection site joint pain].Knee joint effusion (left knee) [injection site joint effusion].Case narrative: based on additional information received on 10-sep-2020 from other healthcare professional (orthopedic technician), this case initially processed as non-serious was upgraded to serious as event of pseudosepsis was updated to serious with criteria of life threatening, medically significant, hospitalisation and required surgical intervention (because its newly added symptoms- knee pain, and knee joint effusion were assessed as serious).This case is linked to case (b)(4)(cluster) and (b)(4)(same patient, multiple devices, right knee).Initial information from united states received on 14-aug-2020 regarding an unsolicited valid serious case from other health professional.This case involves a 68 years old male patient (182.8 cm and 100.24 kg) who experienced pseudosepsis (left knee), after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) in left knee.The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection (synvisc one) (strength: 48 mg/ 6 ml, syringe) in left knee at the dose of 6 ml (48 mg) once (one use, one dose) via intra-articular route for oa (osteoarthritis)(lot - 9rsl043; expiration date: sep-2022).On same day after the injection, the patient had pseudosepsis, knee pain (injection site joint pain), knee joint effusion (injection site joint effusion) in left knee.The events of pseudosepsis, knee pain, and knee joint effusion were assessed serious due to being considered as life threatening, medically significant, required hospitalisation and surgical intervention.The patient was hospitalised on (b)(6) 2020 and on same day had surgery on left knee to have left knee chondroplasty, incision and drainage.On (b)(6)2020, the patient was discharged and recovered from knee pain and knee joint effusion.Reportedly, the patient was hospitalised for only 1 day.Action taken: not applicable.Corrective treatment: left knee chondroplasty, incision and drainage.The patient outcome is reported as unknown product technical complaint (ptc) was initiated with global ptc number (b)(4) on 10-sep-2020 for product.Batch number: 9rsl043.Device not returned.The production and quality control documentation for lot 9rsl043 expiration date sep-2022 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 9rsl043 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 16-nov-2020 there are 4 complaints on file for lot# 9rsl043 and all related sublots.4 complaints are on file for lot# 9rsl043: (1) luer lok defect and (3) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling"쳌 to determine if a capa (corrective and preventive action) was required.Final investigation complete date: 17-nov-2020.Additional information was received on 10-sep-2020 from other healthcare professional (orthopedic technician).Symptoms knee pain, and knee joint effusion were added for pseudosepsis.Event of pseudosepsis was upgraded to serious and overall case seriousness was also updated.Suspect details were updated.Clinical course was updated.Text was amended accordingly.Follow-up information was received with clock start date of 10-sep-2020 from other healthcare professional.Gptc number was added.No significant information was received.Additional information was received on 17-nov-2020 from healthcare professional.Global ptc results added.Expiry date added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10535090
• MDR Text Key: 213855489
• Report Number: 2246315-2020-00133
• 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: 11/19/2020

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: 09/01/2022
• Device Lot Number: 9RSL043
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Weight: 100