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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Nausea (1970); Vomiting (2144)

Event Date 11/03/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2017 from the physician.This case concerns a male patient (age unspecified) who received treatment with synvisc one injection and after unknown latency the patient experienced fever.No relevant medical history, past medications and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (dose, indication and expiration date: not reported; lot number: 7rsl021).On an unknown date in 2017, unknown latency of receiving the injection the patient experienced fever and chills and was hospitalized for four days.It was reported that the patient was "feeling much better" and was having relief in his knee from the injection.Corrective treatment: not reported a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: in-patient hospitalization pharmacovigilance comment: sanofi company comment dated (b)(6) 2017: this case concerns a patient who received treatment with synvisc one and was later hospitalized due to fever and chills.A significant temporal relationship can be established and causal role of suspect product in occurrence of the event cannot be denied; however, due to lack of information regarding medical history, concurrent condition and past drugs precludes complete medical assessment of the case.

Event Description

This unsolicited case from united states was received on 04-dec-2017 from the physician.This case concerns a male patient (age unspecified) who received treatment with synvisc one injection and after unknown latency the patient experienced fever.No relevant medical history, past medications and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (dose, indication and expiration date: not reported; lot number: 7rsl021).On an unknown date in 2017, unknown latency of receiving the injection the patient experienced fever and chills and was hospitalized for four days.It was reported that the patient was "feeling much better" and was having relief in his knee from the injection.Corrective treatment: not reported for all the events outcome: unknown for all 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criterion: in-patient hospitalization for all the events additional information was received on 04-dec-2017 and 14-dec-2017 (processed together with clock start date of 04-dec-2017).Event of device malfunction was added.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 04-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and was hospitalized due to fever and chills.The events are temporally related to device.Moreover, 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 unsolicited case from united states was received on 04-dec-2017 from the physician.This case concerns a male patient (age unspecified) who received treatment with synvisc one injection and 01 day later the patient experienced fever, 01 day later felt nauseated, vomiting, increased pain, swelling and after unknown latency experienced bilateral knee reaction to synvisc one injection.Also, device malfunction was identified for the reported lot number.The patient was allergic to sulfamethoxazole/ trimethoprim (bactrin)- nausea.Relevant concomitant medication included enalapril maleate (enalapril), atenolol, metformin hydrochloride (metformin), empagliflozin (jardiance), acetylsalicylic acid (aspirin).On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml, once (indication: not reported; lot number: 7rsl021 and expiration date: may-202).On an unknown date, after unknown latency, the patient had bilateral knee reaction to synvisc one injection.On (b)(6) 2017, 01 day after receiving synvisc one injection, the patient went to emergency room (er) and had increased pain, swelling and was placed on prednisone.The same day, the patient also experienced increased swelling with fever and pain, nauseated with vomiting.On (b)(6) 2017, the patient was seen in office for follow up, called office on (b)(6) 2017 for recheck.It was reported that the patient experienced fever and chills and was hospitalized.Labs were ordered and patient was admitted to the hospital on (b)(6) 2017.On (b)(6) 2017, no organism was seen in gram stain test and no organism was seen (negative) in cultured (aerobic and anaerobic).The patient was released on (b)(6) 2017 with oral antibiotics.It was reported that the patient was "feeling much better" and was having relief in his knee from the injection.On (b)(6) 2017, the patient recovered from fever, nauseated, vomiting, increased pain, swelling.Corrective treatment: prednisone for swelling, increased pain; oral antibiotics for vomiting, nauseated, fever; not reported for rest of the events outcome: unknown for device malfunction, bilateral knee reaction to synvisc one injection; recovered/resolved 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criterion: in-patient hospitalization for fever, nauseated, vomiting and required intervention and in-patient hospitalization for increased pain, swelling and device malfunction additional information was received on 04-dec-2017 and 14-dec-2017 (processed together with clock start date of 04-dec-2017).Event of device malfunction was added.Global ptc number and ptc results were added.Text was amended accordingly.Follow up information was received on 18-dec-2017.No new information was received.Additional information was received on 07-feb-2018 from medical assistant.Additional events of nauseated, vomiting, increased pain, swelling and bilateral knee reaction to synvisc one injection were added with details.Dosing details of the suspect product was updated.Concomitant medications, concurrent condition, past drug was added.Outcome of fever was updated to recovered.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 07-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and was hospitalized due to fever, chills, nausea and vomiting.The events are temporally related to device.Moreover, 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: 7128510
• MDR Text Key: 95233907
• Report Number: 2246315-2017-00248
• Device Sequence Number: 1
• Product Code: MOZ
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 12/04/2017; 02/07/2018
• Supplement Dates FDA Received: 12/29/2017; 02/21/2018
• Patient Sequence Number: 1
• Treatment: ASPIRIN(CON.); ATENOLOL(CON.); BACTRIN(PREV.); ENALAPRIL(CON.); JARDIANCE(CON.); METFORMIN(CON.)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR