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 Problem Inflammation (1932)

Event Type  malfunction  

Event Description

This case is cross referred with the cases (b)(4) (cluster).This unsolicited case from united states was received on 31-jan-2018 from a health care professional.This case concerns female patient of unknown age who received treatment with synvisc one injection and after unknown latency the patient experienced inflammatory reaction to the injection.Also, device malfunction was identified for the reported lot number.Patient's concomitant medications included lidocaine, bupivacaine, methylprednisolone acetate, betamethasone acetate and sodium phosphate.No relevant medical history and past medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml, once (lot number 7rsl021 and expiration date: may- 2020) for left knee primary osteoarthritis.On an unknown date, after unknown latency of receiving the injection the patients had inflammatory reaction to the injection.It was reported that she had done quite a bit of exercise and feels improved.Also, reported that the physician would set her up for a magnetic resonance imaging (mri) of the left knee this spring and the patient would call to schedule as needed.Corrective treatment: bit of exercise for inflammatory reaction to the injection outcome: recovering/resolving for the event of inflammatory reaction to the injection and unknown for the event of device malfunction a pharmaceutical technical complaint (ptc) was initiated.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: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 12-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had inflammatory reaction to the injection.A temporal relationship cannot be established with the product administration as the exact dates are not known.But since 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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7295975
• MDR Text Key: 101488211
• Report Number: 2246315-2018-00308
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• 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: 01/31/2018
• 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 Weight: 71