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 Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 15-jan-2018 from patient this case concerns a female patient (age unspecified) who received treatment with synvisc one and after an unknown latency patient was unable to bend on her left leg, unable to bear weight on her left leg, use crutches, swollen to about the size of a basketball and extracted fluid from left knee.Also, device malfunction was identified for the reported lot number.No medical history, concomitant medications and concurrent conditions were reported.Patient reported receiving synvisc-one injection previously in (b)(6) of 2013.There was no reaction from this injection that was in the left knew as well.Patient found this injection "helpful in 2013 and it lasted about 4 years".Patient doing better at this time.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (lot number: 7rsl021 and expiration date: 31-may-2020) for osteoarthritis in the left knee.It was reported that patient endured an "intense and immediate reaction".On an unknown date in (b)(6) 2017, latency unknown, patient left knee was swollen to about the size of a basketball.Patient was out of work for 1 week, and had to use crutches, and was unable to bend or bear weight on her left leg.Patient notified doctor on (b)(6) 2017, and was able to get consumer in the same day and extracted fluid from left knee and it was sent for laboratory testing.Patient stated that doctor removed 3 large syringes of fluid plus a couple smaller tubes.Patient used meloxicam 15mg once per day, as well as used ice, elevation and rest to treat symptoms.Patient stated that the results from the lab came back negative.Patient stated that because of this injection it included 6 follow up visits.Corrective treatment: not reported for device malfunction; use crutches for unable to walk; meloxicam, ice, elevation, rest for rest events outcome: unknown for all the 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 18-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced weight bearing difficulty, joint range of motion decreased and unable to walk.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.

• 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: 7230124
• MDR Text Key: 99092016
• Report Number: 2246315-2018-00180
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• 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