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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Unspecified Infection (1930); Arthralgia (2355); Joint Swelling (2356)

Event Date 11/21/2017

Event Type  malfunction  

Event Description

This case was cross referred with cases: (b)(4).This spontaneous case from united states was received on 13-feb-2018 from healthcare professional this case concerns (b)(6) female patient who initiated treatment with synvisc one and on the same day had unable to ambulate, severe pain and swelling; after unknown latency had infection.Also device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.Patient had no known drug allergies.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once osteoarthritis bilateral knees (batch/ lot number: 7rsl021 and expiry date: may-2020).On the same day, patient had severe pain and swelling and was bedridden with fever and was unable to ambulate.On an unknown date, latency unknown, patient had infection.On (b)(6) 2018 patient recovered from unable to ambulate, severe pain and swelling corrective treatment: cefalexin monohydrate (keflex) for infection; meloxicam (mobic) for severe pain; not reported for other events.Outcome: unknown for infection and device malfunction; recovered for rest events seriousness criteria: medically significant for all events.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.Pharmacovigilance comment: sanofi company comment dated 22-feb-2018: this case concerns a patient who suffered from fever due to infection, being unable to ambulate, knee pain and swelling of knees after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between the events and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility of the events to the product 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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7298839
• MDR Text Key: 101494263
• Report Number: 2246315-2018-00350
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• 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): Other
• Patient Age: 63 YR