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)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 17-jan-2018 from patient daughter.This case concerns a (b)(6) female patient who received treatment with synvisc one and on the same day had hard time walking, could barely walk, it was a couple hours for her to walk and put some weight on it (walking difficulty and weight bearing difficulty), swelling, very swollen and really painful, still experiencing pain.Also, device malfunction was identified for the reported lot number.No past drugs, concomitant medications and concurrent conditions were reported.Patient was not experiencing any pain prior to the injection.Before the injection she could bear weight.On (b)(6) 2017, around 14:00, patient received treatment with intra articular synvisc one injection (lot number: 7rsl021; dose, frequency and expiration date: not reported) for arthritis in left knee.On the same day, after the injection, patient began to have the symptoms at 2:30 am following the injection.Symptoms included swelling, hard time walking.Patient daughter came over that morning and patient tried to go to sleep but it was really painful.At 7am patient could have been getting them for several years.Patient daughter iced it, put trolamine salicylate and gave her paracetamol.It took patient about another day.It was a couple hours for patient to walk and put some weight on it.Patient was still experiencing pain so patient daughter had to ice and elevate it.By the next day patient was doing much better.It was said that patient every now and then felt something in there.It was stated that if patient had one (fever) it would be not that bad.Corrective treatment: ice, trolamine salicylate (aspercreme), paracetamol (tylenol),elevate for all events.Outcome: recovering 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.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 17-jan-2018.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced difficulty walking, knee swelling, knee pain.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.D barely walk.It was very swollen.

• 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: 7258984
• MDR Text Key: 100258294
• Report Number: 2246315-2018-00239
• Device Sequence Number: 0
• Product Code: MOZ
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/09/2018
• 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: 88 YR