MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE (SYNVISC ONE); INTRA-ARTICULAR HYALURONIC ACID

Lot Number 6RSL015B

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Missing Value Reason (3192)

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 03/01/2017

Event Type  Injury  

Event Description

This unsolicited case from spain was received on 03- apr-2017 and 04-apr-2017 (both information processed together with clock start date 03-apr-2017) from a physician (traumatologist).This case involves a (b)(6) female patient who received treatment with synvisc one and after 15 days experienced difficulty of mobility, swelling in both knees, pain in both knees and after few days experienced intraarticular fluid removed.No past drug or concurrent condition was reported.Concomitant medications included omeprazole and antiinflammatory drug.On an unknown date, 2 years prior to the notification, patient was treated with hyaluronic acid (nos) for arthrosis and worked perfectly.On an unknown date in (b)(6) 2017, the patient received treatment with synvisc one injection at a dose of 6 ml once (route: not provided; batch/lot: 6rsl015b; expiration date: apr-2019) in each knee for arthrosis grade 3.On an unknown date in (b)(6) 2017, 15 days after the injections of synvisc one, the patient experienced swelling in both knees with pain and difficulty of mobility.On that same day the patient initiated etoricoxib (arcoxia) 60 mg twice a day as corrective treatment but it did not work.During the weekend (i.E.(b)(6) 2017) the patient got worse.On (b)(6) 2017, during the visit with the traumatologist, the treatment with etoricoxib (arcoxia) was withdrawn.The traumatologist also stated that intraarticular fluid was removed from the patient, 34 ml in the right knee and 25 ml in the right knee.Additionally, the traumatologist administered 1 ml of triamcinolone acetonide (trigon depot) in each knee as corrective treatment.Corrective treatment: etoricoxib (arcoxia) for difficulty of mobility, pain in both knees; etoricoxib (arcoxia), intraarticular fluid removed and triamcinolone acetonide (trigon depot) for swelling in both knees.Outcome: unknown for intraarticular fluid removed; recovering/resolving for rest of the events.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: medically significant for difficulty of mobility, swelling in both knees, pain in both knees.Reporter causality: related.Pharmacovigilance comment: (b)(4) comment dated 7-apr-2017: this case concerns a patient who received treatment with synvisc one for grade 3 arthrosis and later experienced mobility difficulty, knee pain and knee swelling.The events have been assessed as related to the suspect product on the basis of temporal gap and site of reaction.Furthermore, causality has been assessed as related with synvisc one by reporting physician.Walking difficulty faced by the patient could be due to knee swelling.

Event Description

This unsolicited case from (b)(6) was received on 03- apr-2017 and 04-apr-2017 (both information processed together with clock start date 03-apr-2017) from a physician (traumatologist).This case involves a (b)(6) female patient who received treatment with synvisc one and after 15 days experienced difficulty of mobility, swelling in both knees, pain in both knees and after few days experienced intraarticular fluid removed.No past drug or concurrent condition was reported.Concomitant medications included omeprazole and antiinflammatory drug.On an unknown date, 2 years prior to the notification, patient was treated with hyaluronic acid (nos) for arthrosis and worked perfectly.On an unknown date in (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot: 6rsl015b; expiration date: apr-2019) in each knee for arthrosis grade 3.On an unknown date in (b)(6) 2017, 15 days after the injections of synvisc one, the patient experienced swelling in both knees with pain and difficulty of mobility.On that same day the patient initiated etoricoxib (arcoxia) 60 mg twice a day as corrective treatment but it did not work.During the weekend (i.E.(b)(6) 2017) the patient got worse.On (b)(6)2017, during the visit with the traumatologist, the treatment with etoricoxib (arcoxia) was withdrawn.The traumatologist also stated that intraarticular fluid was removed from the patient, 34 ml in the right knee and 25 ml in the right knee.Additionally, the traumatologist administered 1 ml of triamcinolone acetonide (trigon depot) in each knee as corrective treatment.During the visit performed on (b)(6) 2017, the physician considered that the patient was recovered from all the events experienced with synvisc one.The physician did not rule out the possibility of readministering synvisc one to the patient later.Corrective treatment: etoricoxib (arcoxia) for difficulty of mobility, pain in both knees; etoricoxib (arcoxia), intraarticular fluid removed and triamcinolone acetonide (trigon depot) for swelling in both knees outcome: unknown for intraarticular fluid removed; recovered for rest of the events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: medically significant for difficulty of mobility, swelling in both knees, pain in both knees.Reporter causality: related.Additional information was obtained on 11-apr-2017 from physician.Outcome was updated for the events of difficulty of mobility, swelling in both knees and pain in both knees was updated from recovering to recovered.Route was updated from unknown to intra-articular.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 11-apr-2017: the follow up information received dose not change previous case assessment.Sanofi company comment dated 7-apr-2017: this case concerns a patient who received treatment with synvisc one for grade 3 arthrosis and later experienced mobility difficulty, knee pain and knee swelling.The events have been assessed as related to the suspect product on the basis of temporal gap and site of reaction.Furthermore, causality has been assessed as related with synvisc one by reporting physician.Walking difficulty faced by the patient could be due to knee swelling.

Event Description

This unsolicited case from (b)(6) was received on 03- apr-2017 and 04-apr-2017 (both information processed together with clock start date (b)(6) 2017) from a physician (traumatologist).This case involves a (b)(6) female patient who received treatment with synvisc one and after 15 days experienced difficulty of mobility, swelling in both knees, pain in both knees and after few days experienced intraarticular fluid removed.No past drug or concurrent condition was reported.Concomitant medications included omeprazole and anti inflammatory drug.On an unknown date, 2 years prior to the notification, patient was treated with hyaluronic acid (nos) for arthrosis and worked perfectly.On an unknown date in (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot: 6rsl015b; expiration date: apr-2019) in each knee for arthrosis grade 3.On an unknown date in (b)(6) 2017, 15 days after the injections of synvisc one, the patient experienced swelling in both knees with pain and difficulty of mobility.On that same day, the patient initiated etoricoxib (arcoxia) 60 mg twice a day as corrective treatment but it did not work.During the weekend (i.E.(b)(6) 2017), the patient got worse.On (b)(6) 2017, during the visit with the traumatologist, the treatment with etoricoxib (arcoxia) was withdrawn.The traumatologist also stated that intraarticular fluid was removed from the patient, 34 ml in the right knee and 25 ml in the right knee.Additionally, the traumatologist administered 1 ml of triamcinolone acetonide (trigon depot) in each knee as corrective treatment.During the visit performed on (b)(6) 2017, the physician considered that the patient was recovered from all the events experienced with synvisc one.The physician did not rule out the possibility of readministering synvisc one to the patient later.Corrective treatment: etoricoxib (arcoxia) for difficulty of mobility, pain in both knees; etoricoxib (arcoxia), intraarticular fluid removed and triamcinolone acetonide (trigon depot) for swelling in both knees.Outcome: unknown for intraarticular fluid removed; recovered for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).The production and quality control documentation for lot 6rsl015b and expiration date apr-2019 was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot/batch record review and lot frequency analysis, no capa was required.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.Seriousness criteria: medically significant for difficulty of mobility, swelling in both knees, pain in both knees.Reporter causality: related.Additional information was obtained on 11-apr-2017 from physician.Outcome was updated for the events of difficulty of mobility, swelling in both knees and pain in both knees was updated from recovering to recovered.Route was updated from unknown to intra-articular.Clinical course updated and text was amended accordingly.Additional information was received on 10-apr-2017.Ptc results were received and added.Text was amended accordingly.Pharmacovigilance comment: "sanofi company comment for follow up dated 11-apr-2017 and 10-apr-2017: the follow up information received dose not changed from previous case assessment." sanofi company comment dated 7-apr-2017: this case concerns a patient who received treatment with synvisc one for grade 3 arthrosis and later experienced mobility difficulty, knee pain and knee swelling.The events have been assessed as related to the suspect product on the basis of temporal gap and site of reaction.Furthermore, causality has been assessed as related with synvisc one by reporting physician.Walking difficulty faced by the patient could be due to knee swelling.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 6492518
• MDR Text Key: 72783058
• Report Number: 2246315-2017-00058
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2017

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: 04/01/2019
• Device Lot Number: 6RSL015B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2017; 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OMEPRAZOLE (CON.)
• Patient Outcome(s): Other
• Patient Age: 64 YR