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 Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2017

Event Type  Injury  

Event Description

This unsolicited case from (b)(6) was received on 23- jun-2017 from the patient's daughter.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and the same day the patient experienced possible allergic reaction and after few days had fluid removed from the affected knee.No relevant medical history and concomitant medications were reported.Past medication included synvisc one (1st at the doctor's office on unspecified date while the 2nd and 3rd at the hospital under ultrasound guidance.The 3rd injection to the left and right knees, administered a week apart, was administered on (b)(6) 2016).On (b)(6) 2017, the patient received fourth intraarticular synvisc one injection, once (dose, indication, lot number and expiration date: not reported) in right knee at the speciality clinic under x-ray guidance.The same day, the patient experienced severe pain, redness and extreme swelling to her right knee.On (b)(6) 2017, as the pain was so severe the patient was brought to emergency of the local hospital.Patient received extensive investigation for infection.Fluids were removed from the affected knee and sent for bacterial culture.Patient was not admitted to hospital.While awaiting for results, patient initially received treatment with intravenous vancomycin twice daily started on (b)(6) 2017 followed by daptomycin once daily on (b)(6) 2017 because twice daily dosing was too difficult and inconvenient.As there were no changes, ceftriaxone was added on (b)(6) 2017.On (b)(6) 2017, the cultures were negative so the antibiotic therapy was discontinued.The patient had been prescribed morphine, then hydromorphone for the pain but that was not enough.Seen by an orthopedic surgeon on (b)(6) 2017, acetaminophen (tylenol) at the dose of 1000 mg every 6 hours with no more than 4 doses per day and ibuprofen at the dose of 200 mg every 6 hours, continuously were added.There was a slight improvement in the swelling of the right knee and redness resolved by (b)(6) 2017 but the pain was unchanged.Test results on (b)(6) 2017 were normal for liver function.Creatine phosphokinase (cpk)/clp was increased.Albumin was a little low and culture in stool was negative.An ultrasound of the right knee performed on (b)(6) 2017 revealed fluids on the knee despite the negative culture.A rheumatologist suggested removing the water on the knee.The orthopedic surgeon suggested not removing.Ice packs were continued.The rheumatologist suggested a possible allergic reaction.Corrective treatment: intravenous antibiotic, vancomycin, daptomycin, ceftriaxone, morphine, hydromorphone, tylenol, ibuprofen for possible allergic reaction.Outcome: not recovered for possible allergic reaction; unknown for fluid was removed from the affected knee.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.

Event Description

This unsolicited case from (b)(6) was received on 23- jun-2017 from the patient's daughter.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and the same day the patient experienced possible allergic reaction and after few days had fluid removed from the affected knee.No relevant medical history and concomitant medications were reported.Past medication included synvisc one (1st at the doctor's office on unspecified date while the 2nd and 3rd at the hospital under ultrasound guidance.The 3rd injection to the left and right knees, administered a week apart, was administered on (b)(6) 2016).On (b)(6) 2017, the patient received fourth intraarticular synvisc one injection, once (dose, indication, lot number and expiration date: not reported) in right knee at the speciality clinic under x-ray guidance.The same day, the patient experienced severe pain, redness and extreme swelling to her right knee.On (b)(6) 2017, as the pain was so severe the patient was brought to emergency of the local hospital.Patient received extensive investigation for infection.Fluids were removed from the affected knee and sent for bacterial culture.Patient was not admitted to hospital.While awaiting for results, patient initially received treatment with intravenous vancomycin twice daily started on (b)(6) 2017 followed by daptomycin once daily on (b)(6) 2017 because twice daily dosing was too difficult and inconvenient.As there were no changes, ceftriaxone was added on (b)(6) 2017.On (b)(6) 2017, the cultures were negative so the antibiotic therapy was discontinued.The patient had been prescribed morphine, then hydromorphone for the pain but that was not enough.Seen by an orthopedic surgeon on (b)(6) 2017, acetaminophen (tylenol) at the dose of 1000mg every 6 hours with no more than 4 doses per day and ibuprofen at the dose of 200mg every 6 hours, continuously were added.There was a slight improvement in the swelling of the right knee and redness resolved by (b)(6) 2017 but the pain was unchanged.Test results on (b)(6) 2017 were normal for liver function.Creatine phosphokinase (cpk)/clp was increased.Albumin was a little low and culture in stool was negative.An ultrasound of the right knee performed on (b)(6) 2017 revealed fluids on the knee despite the negative culture.A rheumatologist suggested removing the water on the knee.The orthopedic surgeon suggested not removing.Ice packs were continued.The rheumatologist suggested a possible allergic reaction.Corrective treatment: intravenous antibiotic, vancomycin, daptomycin, ceftriaxone, morphine, hydromorphone, tylenol, ibuprofen for possible allergic reaction.Outcome: not recovered for possible allergic reaction; unknown for fluid was removed from the affected knee a pharmaceutical technical complaint (ptc) was initiated and 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.Additional information was received on 29-jun-2017.Global ptc number and results were added.Text was amended accordingly.

Event Description

This unsolicited case from (b)(6) was received on (b)(6) 2017 from the patient's daughter.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and vancomycin the same day the patient experienced possible allergic reaction; after unknown latency patient had yeast infection in mouth, bacterial infection in gut no relevant medical history and concomitant medications were reported.Past medication included synvisc one (1st at the doctor's office on unspecified date while the 2nd and 3rd at the hospital under ultrasound guidance.The 3rd injection to the left and right knees, administered a week apart, was administered on (b)(6) 2016).On (b)(6) 2017, the patient received fourth intraarticular synvisc one injection, once (dose, indication, lot number and expiration date: not reported) in right knee at the speciality clinic under x-ray guidance.The same day, the patient experienced severe pain, redness and extreme swelling to her right knee.On (b)(6) 2017, as the pain was so severe the patient was brought to emergency of the local hospital.Patient received extensive investigation for infection.Fluids were removed from the affected knee and sent for bacterial culture.Patient was not admitted to hospital.While awaiting for results, patient initially received treatment with intravenous vancomycin twice daily started on (b)(6) 2017 followed by daptomycin once daily on (b)(6) 2017 because twice daily dosing was too difficult and inconvenient.As there were no changes, ceftriaxone was added on (b)(6) 2017.On (b)(6) 2017, the cultures were negative so the antibiotic therapy was discontinued.The patient had been prescribed morphine, then hydromorphone for the pain but that was not enough.Seen by an orthopedic surgeon on (b)(6) 2017, acetaminophen (tylenol) at the dose of 1000mg every 6 hours with no more than 4 doses per day and ibuprofen at the dose of 200mg every 6 hours, continuously were added.There was a slight improvement in the swelling of the right knee and redness resolved by (b)(6) 2017 but the pain was unchanged.Test results on (b)(6) 2017 were normal for liver function.Creatine phosphokinase (cpk)/clp was increased.Albumin was a little low and culture in stool was negative.An ultrasound of the right knee performed on (b)(6) 2017 revealed fluids on the knee despite the negative culture.A rheumatologist suggested removing the water on the knee.The orthopedic surgeon suggested not removing.Ice packs were continued.The rheumatologist suggested a possible allergic reaction.On an unknown date, the patient completed treatment with vancomycin.As of (b)(6) 2017, the redness was gone, inflammation had decreased (still present), pain had decreased (still present).On an unknown date in 2017, the patient experienced bacterial infection in gut, diarrhea, yeast infection in mouth (latency: unknown).Action taken: unknown for vancomycin corrective treatment: intravenous antibiotic, vancomycin, daptomycin, ceftriaxone, morphine, hydromorphone, tylenol, ibuprofen for possible allergic reaction; not reported for yeast infection in mouth and bacterial infection in gut outcome: not recovered for possible allergic reaction; unknown for yeast infection in mouth and bacterial infection in gut a pharmaceutical technical complaint (ptc) was initiated and 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: important medical event for bacterial infection in gut; required intervention for possible allergic reaction additional information was received on 29-jun-2017.Global ptc number and results were added.Text was amended accordingly.Additional information was received on 01-aug-2017.Additional suspect drug of vancomycin was added with details.Additional events of yeast infection in mouth and bacterial infection in gut were added along with details.Previously captured event of fluid was removed from the affected knee was updated to associated symptom.Seriousness was added.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 4-aug-2017: this case concerns a patient who received treatment with synvisc one and later experienced bacterial infection in gut.The causal role of suspect product in occurrence of the event cannot be suspected as there is no pharmacological plausibility of event occurring due to suspect product.Furthermore, as per reported information patient experienced these events as side effects of antibiotics.

• 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: 6685648
• MDR Text Key: 79052539
• Report Number: 2246315-2017-00105
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 06/23/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• 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 UNKNOWN; SYNVISC ONE (PREV.) - STOP
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR