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

Lot Number 5RSA021Z

Device Problem Aborted Charge (2288)

Patient Problem Joint Disorder (2373)

Event Date 01/01/2016

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2016 from a nurse.This case concerns a (b)(6) female patient who initiated treatment with synvisc on (b)(6) 2016 and later experienced recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee and was non weight bearing on crutches.No medical history, concomitant medications and concurrent conditions were reported.The patient had no known allergies.Past drug included four sets of sodium hyaluronate (supartz) injections given at six to nine month intervals.On (b)(6) 2016, the patient initiated treatment with intra-articular synvisc injection twice (dose: not provided) (batch/lot number: (b)(4) and expiration date: 31-aug-2018) in her left knee for osteoarthritis.On an unknown date in (b)(6) 2016, for a couple of days, the patient experienced left knee effusion.On (b)(6) 2016, the patient saw her doctor and it was decided to hold synvisc.The left knee effusion resolved and on (b)(6) 2016, the patient received the second injection of synvisc.The same day, in the evening, patent had reaction with the second series injection of synvisc and experienced a severe effusion of her left knee.On (b)(6) 2016, the doctor diagnosed a "3plus" effusion in the patient's left knee which he drained and then injected dexamethasone.On an unknown date in 2016, the patient was non-weight bearing on crutches.Five days later, the patient's left knee was back to normal with no other adverse effects.Action taken: stopped temporarily corrective treatment: dexamethasone and drained for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee; not reported for patient was non weight bearing on crutches outcome: recovered/ resolved for all events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: required intervention for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee.

Event Description

This unsolicited device case from united states was received on 03-mar-2016 from a nurse.This case concerns a (b)(6) female patient who initiated treatment with synvisc on(b)(6) 2016 and later experienced recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee and was non weight bearing on crutches.No medical history, concomitant medications and concurrent conditions were reported.The patient had no known allergies.Past drug included four sets of sodium hyaluronate (supartz) injections given at six to nine month intervals.On (b)(6) 2016, the patient initiated treatment with intra-articular synvisc injection twice (dose: not provided) (batch/lot number: 5rsa021z and expiration date: 31-aug-2018) in her left knee for osteoarthritis.On an unknown date in jan-2016, for a couple of days, the patient experienced left knee effusion.On (b)(6) 2016, the patient saw her doctor and it was decided to hold synvisc.The left knee effusion resolved and on (b)(6) 2016, the patient received the second injection of synvisc.The same day, in the evening, patent had reaction with the second series injection of synvisc and experienced a severe effusion of her left knee.On (b)(6) 2016, the doctor diagnosed a "3plus" effusion in the patient's left knee which he drained and then injected dexamethasone.On an unknown date in 2016, the patient was non-weight bearing on crutches.Five days later, the patient's left knee was back to normal with no other adverse effects.Action taken: stopped temporarily.Corrective treatment: dexamethasone and drained for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee; not reported for patient was non weight bearing on crutches.Outcome: recovered/ resolved for all events.A pharmaceutical technical complaint (ptc) was initiated with global ptc umber: (b)(4).The production and quality control documentation for lot # 5rsa021z expiration date (08/2018) 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 # 5rsa021z no capa was required.Sanofi genzyme 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.As of 08-mar-16, there were a total of (b)(4) complaints on file for lot# 5rsa021z: (b)(4) adverse event reports, (b)(4) extrusion difficulty and (b)(4) detached luer-lok hub.(b)(4) genzyme would continue to monitor complaints as stated in product complaint handling to determine if a capa was required.Seriousness criteria: required intervention for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee.Additional information was received on 08-mar-2016.Global ptc number with results was added and the text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5491856
• MDR Text Key: 40046156
• Report Number: 2246315-2016-00042
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Lot Number: 5RSA021Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR