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

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

Patient Problems Muscular Rigidity (1968); Swelling (2091); Hot Flashes/Flushes (2153)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Based upon additional information received on 28-feb- 2017, the case initially assessed as non-serious was upgraded to serious as the serious events of all muscles in patient legs being sore, legs were very hot and swollen and legs were very stiff with the seriousness criterion of required intervention were added.This unsolicited case from (b)(6) was received on 28-feb-2017 from a patient.This case involves a female patient of unknown age who received treatment with synvisc one and after an unknown latency had muscle and ankle tightening, hard to bend knee when walking, knee hot, knee swollen, pain has started in back and was finding it very hard to bend knee when walking and after few days all muscles in patient legs being sore, legs were very hot and swollen and legs were very stiff.The patient's medical history, past drugs, concomitant medications and concurrent conditions were not provided.On (b)(6) 2017, the patient received treatment with synvisc one injection, once (dose, route, indication, batch/lot number and expiry date: not reported) in both knees.The patient rested 48 hours after the injection.On an unknown date in (b)(6) 2017, after an unknown latency, side effects experienced since that included muscle and ankle tightening, knees hot and swollen.The patient applied ice packs which helped a bit, followed instructions and rested for first few days after injection.Since an unknown date in (b)(6) 2017, after an unknown latency, pain had now started to occur in her back and was finding it very hard to bend knee when walking.The patient had an appointment with general practitioner (gp) on (b)(6) 2017.On an unknown date in 2017, few days after the injection, all muscles in patient's legs were being sore, legs were very hot and swollen and legs were very stiff.It was reported that the patient had been getting treated with the anti-inflammatories celecoxib (celebrex) and prednisone (2 doses on (b)(6) 2017 (today), 1 dose on (b)(6) 2017 (tomorrow) and 1 dose on thursday).The patient was treating her symptoms with a cold pack also.The patient noted that she was on her legs longer at work.The patient was given the injection where she was living at that time and now she lived somewhere else.It was reported that the patient needed to have knee reconstruction on left side.No further information was provided.Corrective treatment: ice packs for muscle and ankle tightening, knee hot and knee swollen; anti-inflammatories celecoxib (celebrex) and prednisone and cold pack for all muscles in patient legs being sore, legs were very hot and swollen, legs were very stiff; not reported for rest of the events.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: required intervention for all muscles in patient legs being sore, legs were very hot and swollen, legs were very stiff.Additional information was received on 28-feb-2017 from the patient.The serious events of all muscles in patient legs being sore, legs were very hot and swollen and legs were very stiff with the seriousness criterion of required intervention were added with details and the case was upgraded to serious.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-feb-2017: this case concerns a female patient who received synvisc one injection for an unknown indication and later had legs being sore, hot, stiff and swollen.The events occurred after treatment with company device and therefore events are temporally related with the drug, therefore causality for events cannot be ruled out completely.However, lack of information regarding patient's underlying condition, medical history and concurrent condition makes the complete case assessment difficult.

Event Description

Based upon additional information received on 28-feb- 2017, the case initially assessed as non-serious was upgraded to serious as the serious events of all muscles in patient legs being sore, legs were very hot and swollen and legs were very stiff with the seriousness criterion of required intervention were added.This unsolicited case from (b)(6) was received on 28-feb-2017 from a patient.This case involves a female patient of unknown age who received treatment with synvisc one and after an unknown latency had muscle and ankle tightening, hard to bend knee when walking, knee hot, knee swollen, pain has started in back and was finding it very hard to bend knee when walking and after few days all muscles in patient legs being sore, legs were very hot and swollen and legs were very stiff.The patient's medical history, past drugs, concomitant medications and concurrent conditions were not provided.On (b)(6) 2017, the patient received treatment with synvisc one injection, once (dose, route, indication, batch/lot number and expiry date: not reported) in both knees.The patient rested 48 hours after the injection.On an unknown date in (b)(6) 2017, after an unknown latency, side effects experienced since that included muscle and ankle tightening, knees hot and swollen.The patient applied ice packs which helped a bit, followed instructions and rested for first few days after injection.Since an unknown date in (b)(6) 2017, after an unknown latency, pain had now started to occur in her back and was finding it very hard to bend knee when walking.The patient had an appointment with general practitioner (gp) on (b)(6) 2017.On an unknown date in 2017, few days after the injection, all muscles in patient's legs were being sore, legs were very hot and swollen and legs were very stiff.It was reported that the patient had been getting treated with the anti-inflammatories celecoxib (celebrex) and prednisone (2 doses on (b)(6) 2017 (today), 1 dose on (b)(6) 2017 (tomorrow) and 1 dose on thursday).The patient was treating her symptoms with a cold pack also.The patient noted that she was on her legs longer at work.The patient was given the injection where she was living at that time and now she lived somewhere else.It was reported that the patient needed to have knee reconstruction on left side.No further information was provided.Corrective treatment: ice packs for muscle and ankle tightening, knee hot and knee swollen; anti-inflammatories celecoxib (celebrex) and prednisone and cold pack for all muscles in patient legs being sore, legs were very hot and swollen, legs were very stiff; not reported for rest of the events.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated with 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 was identified and mitigated through the ncr process.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.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: required intervention for all muscles in patient legs being sore, legs were very hot and swollen, legs were very stiff.Additional information was received on 28-feb-2017 from the patient.The serious events of all muscles in patient legs being sore, legs were very hot and swollen and legs were very stiff with the seriousness criterion of required intervention were added with details and the case was upgraded to serious.Clinical course updated and text amended accordingly.Additional information was received on 16-mar-2017.Ptc results were added and the text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 16-mar-2017: the follow up information received does not change the previous case assessment.Sanofi company comment for follow up dated 28-feb-2017: this case concerns a female patient who received synvisc one injection for an unknown indication and later had legs being sore, hot, stiff and swollen.The events occurred after treatment with company device and therefore events are temporally related with the drug, therefore causality for events cannot be ruled out completely.However, lack of information regarding patient's underlying condition, medical history and concurrent condition makes the complete case assessment difficult.

• 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: 6402399
• MDR Text Key: 69868363
• Report Number: 2246315-2017-00037
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• 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
• Patient Outcome(s): Required Intervention