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 Erythema (1840); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 11/22/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2018 from patient.This case involves a patient (demographics: not provided) who received treatment with synvisc one and after few days the patient had trouble walking, pain, redness and swelling (after unknown latency).Also, device malfunction was identified for the reported lot number.No medical history, past drugs, concurrent condition was provided.Concomitant medications included simvastatin, amlodipine, alprazolam, metoprolol tartrate (metoprolol), fish oil, low dose acetylsalicylic acid (aspirin).On an unknown date in 2017, the patient initiated treatment with intra-articular, injection (dose: not provided; batch/lot number: 7rsl021) for pain relief for knee.It was reported that the patient had an injection of synvisc one which was from a contaminated lot lot #7rsl021.On (b)(6) 2017 (after unknown latency), the patient experienced pain, swelling, redness, trouble walking, was later called by physician to be informed of the contamination.The patient had to go to the hospital for blood tests, apparently the blood tests were satisfactory.The blood tests were done a month later but had lesser levels of pain and swelling for 2 months.It was reported that the problem did not stop after the patient reduced the dose or stopped taking or using the product.Corrective treatment: not reported for all events.Outcome: recovering for pain, swelling; unknown for rest of the events.Seriousness criterion: important medical event for device malfunction was identified for the reported lot number.A product technical complaint (ptc) was initiated and results were pending for the same.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.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who suffered experienced to being unable to walk after receiving synvisc one injection from the recalled lot.The temporal relationship can still 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: 7510564
• MDR Text Key: 108734713
• Report Number: 2246315-2018-00474
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• 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