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

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 07-dec-2017 from a non-healthcare professional.This case concerns a female patient of unknown age who received treatment with synvisc one and later few days after starting treatment had pseudo sepsis.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021, expiry date: unknown).On (b)(6) 2017, the patient had discomfort.On an unknown date in (b)(6) 2017, few years after starting treatment with synvisc one, the patient was diagnosed with pseudo sepsis requiring 2-3 days in the hospital.The patient called their office on (b)(6) 2017 requesting narcotic pain medications.It was reported that the doctor was not able to prescribe anything due to her being out of state and via telephone recommended her to go to an urgent care for pain medication and treatment.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: hospitalization/prolongation.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.

Event Description

This unsolicited case from united states was received on 07-dec-2017 from a non-healthcare professional.This case concerns a female patient of unknown age who received treatment with synvisc one and later few days after starting treatment had pseudo sepsis.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021, expiry date: unknown).On (b)(6)-2017, the patient had discomfort.On an unknown date in (b)(6)-2017, few years after starting treatment with synvisc one, the patient was diagnosed with pseudo sepsis requiring 2-3 days in the hospital.The patient called their office on (b)(6)-2017 requesting narcotic pain medications.It was reported that the doctor was not able to prescribe anything due to her being out of state and via telephone recommended her to go to an urgent care for pain medication and treatment.Action taken: unknown.Corrective treatment: not reported for pseudo sepsis.Outcome: unknown for both events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: hospitalization/prolongation for both events additional information was received on 07-dec-2017 and 08-jan-2018 (both the information was processed together with clock start date of 07-dec-2017).Additional event of device malfunction was added along with details.Global ptc number and results were added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 07-dec-2017: this case concerns a female patient who received synvisc one injection from the recalled lot and had pseudosepsis.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

Event Description

This case is cross referenced with cases: (b)(4) (cluster).This unsolicited case from united states was received on 07-dec-2017 from a non-healthcare professional.This case concerns a female patient (b)(6) years old who received treatment with synvisc one, difficulty walking (latency: 1 day) and severe pain of both knees (latency: 1 days) and later few days after starting treatment had pseudo sepsis.Also device malfunction was identified for the reported lot number.No past drug or concurrent condition was provided.Patient's medical history included blood pressure, thyroid disorder and cholesterol.Concomitant medications included amlodipine, centrum, doxazosin mesilate (doxazosin), levothyroxine sodium (levothyroxine) and simvastatin.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose: unknown) (batch/lot number: 7rsl021, expiry date: unknown) once for osteoarthritis.On (b)(6) 2017, 1 day after receiving alemtuzumab, patient experienced difficulty walking and severe pain of both knees.On an unknown date, the patient had discomfort.On an unknown date in (b)(6) 2017, few years after starting treatment with synvisc one, the patient was diagnosed with pseudo sepsis requiring 2-3 days in the hospital.The patient called their office on (b)(6) 2017 requesting narcotic pain medications.It was reported that the doctor was not able to prescribe anything due to her being out of state and via telephone recommended her to go to an urgent care for pain medication and treatment.Corrective treatment: not reported for all events outcome: recovered for difficulty walking and severe pain of both knees; unknown for rest of the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: hospitalization/prolongation for pseudo sepsis and device malfunction reporter causality: events were related to product: yes additional information was received on 07-dec-2017 and 08-jan-2018 (both the information was processed together with clock start date of 07-dec-2017).Additional event of device malfunction was added along with details.Global ptc number and results were added.Clinical course was updated and text was amended accordingly.Additional information was received on 13-feb-2018 from patient.Suspect medication therapy details, indication and action taken updated.Additional events of difficulty walking and severe pain of both knees were added.Concomitant medication and medical history added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 13-feb-2018: this case concerns a female patient who received synvisc one injection from the recalled lot and had pseudosepsis.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7156223
• MDR Text Key: 96128663
• Report Number: 2246315-2017-00285
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Patient Sequence Number: 1
• Treatment: AMLODIPINE(CON.); CENTRUM(CON.); DOXAZOSIN(CON.); LEVOTHYROXINE(CON.); SIMVASTATIN(CON.)
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR