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

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

Patient Problems Arthritis (1723); Aspiration/Inhalation (1725); No Code Available (3191)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment for follow-up dated 16-nov-2018: follow up information received does not change previous case assessment.The case concerns a female patient who received treatment with hylan g-f 20, sodium hyaluronate and had walking disability and arthritis.The temporal relationship of the adverse event cannot be denied, however lack of detailed information regarding other medications, patient's risk factors and medical history would aid in comprehensive assessment of the case.

Event Description

Prevented her from walking [walking disability] ; inflammation in right knee [joint inflammation] ; high glucose [synovial fluid glucose present] ; 60 ml liquid was removed [joint effusion] ; case narrative: upon internal review on (b)(6) 2018, this case has been upgraded to serious from non-serious.This case is linked to case (b)(4).(same patient).Initial information received from (b)(6) on (b)(6) 2018 regarding an unsolicited valid serious case received from a pharmacist who was patient.This case involves a (b)(6) female patient who experienced inflammation in right knee, 60 ml liquid was removed, prevented her from walking and high glucose, while 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.Concomitant medications included levothyroxine sodium (eutirox) for hypothyroidism.On (b)(6) 2018, the patient started taking synvisc one 1 df 1x via intra-articular route (with an unknown batch number) for osteoarthritis.On the same day, knee started to inflame.On (b)(6) 2018, patient went to emergency room where they removed 60 ml of liquid of her knee.The liquid was analyzed and high glucose, high proteins, 13000 leukocytes and pmn 73% were found.She also stated that inflammation prevented her from walking.The patient was recovered from the reaction occurred in (b)(6) 2018.Relevant laboratory test results included: aspiration joint - on (b)(6) 2018: 60 ml [60 ml fluid was aspirated].Synovial fluid glucose - on an unknown date: 79.02 g/l [high].Synovial fluid protein - on an unknown date: 49.12 g/l [high].Synovial fluid white blood cells - on an unknown date: 13000 mm3.Synovial fluid white blood cells positive - on an unknown date: 73 %.Final diagnosis was inflammation in right knee, 60 ml liquid was removed, high glucose and prevented her from walking.Action taken: not applicable.Corrective treatment: paracetamol for inflammation in right knee.Outcome: recovered for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc one.Batch number: unknown; local ptc number: (b)(4); 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 is identified and mitigated through the ncr 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 adverse events to determine if a capa is required.Seriousness criteria: medically significant for inflammation in right knee and prevented her from walking.Additional information was received on (b)(6) 2018.Global ptc number and its results were added.Upon internal review this case has been upgraded to serious from non-serious.Additional information received on (b)(6) 2018 from the patient.Outcome for event inflammation in right knee updated from recovering to recovered.Clinical course updated and text amended accordingly.Additional information received on (b)(6) 2018.Analysis of similar incidents added to the case.Upon internal review on (b)(6) 2018, outcome for events 60 ml liquid was removed, prevented her from walking and high glucose was updated to recovered/resolved from unknown.Also, the country was updated in the narrative.

Event Description

Prevented her from walking [walking disability].Inflammation in right knee [joint inflammation].High glucose [synovial fluid glucose present].60 ml liquid was removed [joint effusion].Case narrative: upon internal review on 25-oct-2018, this case has been upgraded to serious from non-serious.This case is linked to case: (b)(4).(same patient).Initial information received from spain on 22-oct-2018 regarding an unsolicited valid serious case received from a pharmacist who was patient.This case involves a 68 years old female patient who experienced inflammation in right knee, 60 ml liquid was removed, prevented her from walking and high glucose, while 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.Concomitant medications included levothyroxine sodium (eutirox) for hypothyroidism.On (b)(6) 2018, the patient started taking synvisc one 1 df 1x via intra-articular route (with an unknown batch number) for osteoarthritis.On the same day, knee started to inflame.On (b)(6) 2018, patient went to emergency room where they removed 60 ml of liquid of her knee.The liquid was analyzed and high glucose, high proteins, 13000 leukocytes and pmn 73% were found.She also stated that inflammation prevented her from walking.The patient was recovered from the reaction occurred in oct-2018.Relevant laboratory test results included: aspiration joint: on (b)(6) 2018: 60 ml [60 ml fluid was aspirated].Synovial fluid glucose: on an unknown date: 79.02 g/l [high].Synovial fluid protein: on an unknown date: 49.12 g/l [high].Synovial fluid white blood cells: on an unknown date: 13000 mm3.Synovial fluid white blood cells positive: on an unknown date: 73 %.Final diagnosis was inflammation in right knee, 60 ml liquid was removed, high glucose and prevented her from walking.Action taken: not applicable.Corrective treatment: paracetamol for inflammation in right knee.Outcome: recovered for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc one.Batch number: unknown; local ptc number: 58761; global ptc number: 56064.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 is identified and mitigated through the ncr 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 adverse events to determine if a capa is required.Seriousness criteria: medically significant for inflammation in right knee and prevented her from walking.Additional information was received on 25-oct-2018.Global ptc number and its results were added.Upon internal review this case has been upgraded to serious from non-serious.Additional information received on 31-oct-2018 from the patient.Outcome for event inflammation in right knee updated from recovering to recovered.Clinical course updated and text amended accordingly.Additional information received on 16-nov-2018.Analysis of similar incidents added to the case.Upon internal review on 22-nov-2018, outcome for events 60 ml liquid was removed, prevented her from walking and high glucose was updated to recovered/resolved from unknown.Also, the country was updated in the narrative.Upon internal review on 09-jan-2019 processed with clock start date of 16-nov-2018 the malfunction field previously captured as yes was removed.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 8193037
• MDR Text Key: 132068575
• Report Number: 2246315-2018-00765
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EUTIROX (LEVOTHYROXINE SODIUM),UNKNOWN; EUTIROX (LEVOTHYROXINE SODIUM),UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR