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

Lot Number UNKNOWN

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

Patient Problems Fever (1858); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 20-dec-2016 from pharmacist.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after unknown latency patient experienced tightness in skin, pain radiating up thigh, fever and swelling.No relevant medical history and concomitant medications were reported.Past drug included synvisc one (in (b)(6) 2016) in right knee without any problems.On (b)(6) 2016, patient received second injection of intra- articular synvisc one injection at the dose of 6 ml once (batch/lot and expiration date not provided) in right knee for osteoarthritis.On an unspecified date in (b)(6) 2016, the patient had some swelling after the injection.Further reported, that the patient had severe swelling, tightness in the skin and pain radiating up to thigh.On (b)(6) 2016, the patient developed fever.Patient sweated through the fever on (b)(6) 2016.On (b)(6) 2016, the patient was prescribed prednisone for 2 days.On an unknown date in (b)(6) 2016, the patient was back to normal.Corrective treatment: prednisone for all the events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Outcome: recovered/ resolved for all the events.Seriousness criterion: required intervention for all the events.Pharmacovigilance comment: sanofi company comment dated 26-dec-2016: this case concerns a patient who received a synvisc one injection in knee and experienced fever, skin tightness and pain radiating to thigh.Local reactions have been generally observed with the application of synvisc one, hence the casual role in the occurrence of events cannot be denied.The event of fever have also been assessed as related to the product as there exists a positive temporal relationship, however lack of information regarding patient's medical history and the conditions under which the patient received the injection and technique used for injection precludes the overall causality assessment.

Event Description

This unsolicited case from united states was received on 20-dec-2016 from pharmacist.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and few days after treatment, patient experienced tightness in skin, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fever, swelling, had fluid retention, could hardly bend leg, had discomfort walking, pain and night sweats.No relevant medical history and concomitant medications were reported.Past drug included synvisc one (in (b)(6) 2016) in right knee (below the knee) without any problems.On an unknown date in (b)(6) 2016, the patient received second injection of intra- articular synvisc one injection at the dose of 6 ml once (batch/lot and expiration date not provided) in right knee (above the knee) for osteoarthritis.On an unspecified date in (b)(6) 2016, the patient had some swelling after the injection.Further reported, that the patient had severe swelling, tightness in the skin and pain radiating up to thigh.On an unknown date in (b)(6) 2016, the patient developed fever.The patient was prescribed prednisone for 2 days.On an unknown date in (b)(6) 2016, the patient was back to normal.On an unknown date in (b)(6) 2016, the patient's right knee was so painful that she could hardly bend her knee and the pain went up my thigh like someone had smacked me with a sledgehammer.On an unknown date in (b)(6) 2016, the patient had fluid retention, pain and night sweats for 1.5 weeks, discomfort walking and pain up her thigh that "went into the bone and ached so bad."the patient still had discomfort and was uncomfortable sleeping.It was reported that the patient contacted her physician at the doctor's office who suggested ice and elevation of leg but declined to order a steroid.It was reported that the patient had some 10 mg predisone left over from something else and she took 2 doses of that.It was reported that the symptoms were subsiding and that her doctor's office was aware of her taking prednisone and of some of the symptoms she reports but not all.Corrective treatment: prednisone, ice, elevation of leg for tightness of chest, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fluid retention, could hardly bend leg, discomfort walking, swelling, pain; prednsione for fever; not reported for night sweats.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 will continue to monitor adverse events to determine if a capa is required.Outcome: recovered for swelling, fever and pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone and tightness in skin; not recovered for fluid retention; recovering for night sweats, pain, discomfort walking, could hardly bend leg seriousness criterion: required intervention for tightness in skin, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fluid retention, could hardly bend leg, discomfort walking, swelling and pain.Additional information was received on 4-jan-2017 from the patient.The additional events of fluid retention, could hardly bend leg, discomfort walking, pain and night sweats were added with details.The event term was updated from "pain radiating up thigh" to "pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone".The suspect product start date was updated from (b)(6) 2016.The event onset date of fever was updated from (b)(6) 2016.The treatment (ice and elevation of leg) for tightness of chest, swelling and pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone was added.Clinical course updated and text was amended accordingly.Additional information was received on 04-jan-2017.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 04-jan-2017: the additional information does not alter previous case assessment.Sanofi company comment for follow up dated 04-jan-2017: this case concerns a patient who received a synvisc one injection in knee and experienced fever, skin tightness, fluid retention, discomfort walking, right leg painful/ pain radiating to thigh and could hardly bend leg.Local reactions have been generally observed with the application of synvisc one, hence a casual role in the occurrence of events cannot be denied.The event of fever and fluid retention have also been assessed as related to the product as there exists a positive temporal relationship, however lack of information regarding patient's medical history and the conditions under which the patient received the injection and technique used for injection precludes the overall causality assessment.

Event Description

This unsolicited case from united states was received on 20-dec-2016 from pharmacist.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and few days after treatment, patient experienced tightness in skin, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fever, swelling, had fluid retention, could hardly bend leg, had discomfort walking, pain and night sweats.No relevant medical history and concomitant medications were reported.Past drug included synvisc one (in (b)(6) 2016) in right knee (below the knee) without any problems.On an unknown date in (b)(6) 2016, the patient received second injection of intra- articular synvisc one injection at the dose of 6 ml once (batch/lot and expiration date not provided) in right knee (above the knee) for osteoarthritis.On an unspecified date in (b)(6) 2016, the patient had some swelling after the injection.Further reported, that the patient had severe swelling, tightness in the skin and pain radiating up to thigh.On an unknown date in (b)(6) 2016, the patient developed fever.The patient was prescribed prednisone for 2 days.On an unknown date in (b)(6) 2016, the patient was back to normal.On an unknown date in (b)(6) 2016, the patient's right knee was so painful that she could hardly bend her knee and the pain went up my thigh like someone had smacked me with a sledgehammer.On an unknown date in (b)(6) 2016, the patient had fluid retention, pain and night sweats for 1.5 weeks, discomfort walking and pain up her thigh that "went into the bone and ached so bad."the patient still had discomfort and was uncomfortable sleeping.It was reported that the patient contacted her physician at the doctor's office who suggested ice and elevation of leg but declined to order a steroid.It was reported that the patient had some 10 mg predisone left over from something else and she took 2 doses of that.It was reported that the symptoms were subsiding and that her doctor's office was aware of her taking prednisone and of some of the symptoms she reports but not all.Corrective treatment: prednisone, ice, elevation of leg for tightness of chest, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fluid retention, could hardly bend leg, discomfort walking, swelling, pain; prednsione for fever; not reported for night sweats.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Outcome: recovered for swelling, fever and pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone and tightness in skin; not recovered for fluid retention; recovering for night sweats, pain, discomfort walking, could hardly bend leg seriousness criterion: required intervention for tightness in skin, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fluid retention, could hardly bend leg, discomfort walking, swelling and pain.Additional information was received on 4-jan-2017 from the patient.The additional events of fluid retention, could hardly bend leg, discomfort walking, pain and night sweats were added with details.The event term was updated from "pain radiating up thigh" to "pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone".The suspect product start date was updated from (b)(6) 2016.The event onset date of fever was updated from (b)(6) 2016.The treatment (ice and elevation of leg) for tightness of chest, swelling and pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone was added.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 04-jan-2017: this case concerns a patient who received a synvisc one injection in knee and experienced fever, skin tightness, fluid retention, discomfort walking, right leg painful/ pain radiating to thigh and could hardly bend leg.Local reactions have been generally observed with the application of synvisc one, hence a casual role in the occurrence of events cannot be denied.The event of fever and fluid retention have also been assessed as related to the product as there exists a positive temporal relationship, however lack of information regarding patient's medical history and the conditions under which the patient received the injection and technique used for injection precludes the overall causality assessment.

Event Description

This unsolicited case from united states was received on 20-dec-2016 from pharmacist.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and few days after treatment, patient experienced tightness in skin, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fever, swelling, had fluid retention, could hardly bend leg, had discomfort walking, pain, night sweats and later the injection was also not working (device ineffective) no relevant medical history and concomitant medications were reported.Past drug included synvisc one (in (b)(6) 2016) in right knee (below the knee: given above the patella) without any problems.On an unknown date in (b)(6) 2016, the patient received second injection of intra- articular synvisc one injection at the dose of 6 ml once (batch/lot and expiration date not provided) in right knee (above the knee) for osteoarthritis.On an unspecified date in (b)(6) 2016, the patient had some swelling after the injection.Further reported, that the patient had severe swelling, tightness in the skin and pain radiating up to thigh.On an unknown date in (b)(6) 2016, the patient developed fever and stiffness.The patient was prescribed prednisone for 2 days.On an unknown date in (b)(6) 2016, the patient was back to normal.On an unknown date in (b)(6) 2016, the patient's right knee was so painful that she could hardly bend her knee and the pain went up my thigh like someone had smacked me with a sledgehammer.On an unknown date in (b)(6) 2016, the patient had fluid retention, pain and night sweats for 1.5 weeks, discomfort walking and pain up her thigh that "went into the bone and ached so bad."the patient still had discomfort and was uncomfortable sleeping.It was reported that the patient contacted her physician at the doctor's office who suggested ice and elevation of leg but declined to order a steroid.It was reported that the patient had some 10 mg prednisone left over from something else and she took 2 doses of that.It was reported that the symptoms were subsiding and that her doctor's office was aware of her taking prednisone and of some of the symptoms she reports but not all.Further reported, the patient met another pa, not the one who gave her the synvisc-one injection in (b)(6)2016.He told her that he no longer gave injections above the patella (where she was injected in (b)(6) 2016) because "people had reactions." he gave her cortisone shot in the right knee because the synvisc-one she received in (b)(6) 2016 was not working and knee was killing her.Corrective treatment: prednisone, ice, elevation of leg for tightness of chest, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fluid retention, could hardly bend leg, discomfort walking, swelling, pain; prednisone for fever; not reported for night sweats.A pharmaceutical technical complaint (ptc) was initiated with global (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 will continue to monitor adverse events to determine if a capa is required.Outcome: recovered for swelling, fever and pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone and tightness in skin; not recovered for fluid retention; recovering for night sweats, pain, discomfort walking, could hardly bend leg.Seriousness criterion: required intervention for tightness in skin, pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone, fluid retention, could hardly bend leg, discomfort walking, swelling and pain.Additional information was received on 4-jan-2017 from the patient.The additional events of fluid retention, could hardly bend leg, discomfort walking, pain and night sweats were added with details.The event term was updated from "pain radiating up thigh" to "pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone".The suspect product start date was updated from (b)(6) 2016.The event onset date of fever was updated from (b)(6) 2016.The treatment (ice and elevation of leg) for tightness of chest, swelling and pain radiating up thigh/ right leg painful/ pain up thigh that went into the bone was added.Clinical course updated and text was amended accordingly.Additional information was received on 04-jan-2017.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 20-feb-2017 from the patient.An additional event of injection not working (device ineffective) with details was added.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 04-jan-2017 and 20-feb-2017: the additional information does not alter previous case assessment.Sanofi company comment for follow up dated 04-jan-2017: this case concerns a patient who received a synvisc one injection in knee and experienced fever, skin tightness, fluid retention, discomfort walking, right leg painful/ pain radiating to thigh and could hardly bend leg.Local reactions have been generally observed with the application of synvisc one, hence a casual role in the occurrence of events cannot be denied.The event of fever and fluid retention have also been assessed as related to the product as there exists a positive temporal relationship, however lack of information regarding patient's medical history and the conditions under which the patient received the injection and technique used for injection precludes the overall causality assessment.

• Brand Name: 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: 6216293
• MDR Text Key: 63664134
• Report Number: 2246315-2016-00185
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2016

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/11/2017; 01/13/2017; 03/01/2017
• 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: SYNVISC ONE(PREV.)-START
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR