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 Joint Swelling (2356); Joint Disorder (2373); Reaction, Injection Site (2442)

Event Date 11/07/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 22-jan-2018 from a healthcare professional.This case concerns a (b)(6) female patient who received treatment with synvisc one and later on the same day had discomfort in her knee, increase in swelling, knee is swollen, after few days had knee is slightly warm and after unknown latency was not feeling good.Also device malfunction was identified for the reported lot number.No concurrent condition was provided.The patient's medical history included: hypertension.The patient had drug allergy to methylprednisolone (leg cramps), cyclobenzaprine and levofloxacin (levaquin).The concomitant medications included: bifidobacterium infantis (align), omeprazole, calcium and hydrochlorothiazide.The patient had past treatment with synvisc injection (benefited from it and she wished to have synvisc once again).On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (batch/lot number: 7rsl021, expiry date: 31-may-2020).It was reported that under sterile conditions patient's left knee was aspirated about 4 cc of fluid was produced and 48 units synvisc one was injected into her left knee.The same day, at night the patient had reaction to synvisc one, experienced increase in swelling, knee was swollen, slightly warm and had discomfort in knee.On an unknown date, the patient was not feeling good.The patient was placed on methylprednisolone (medrol) dose pack.It was reported that the patient was to ice her knee.On (b)(6) 2017, the patient recovered from swelling and discomfort in knee.It was reported that if patient was still hurting, her knee would be aspirated and depo-moderol would be given.Corrective treatment: methylprednisolone (medrol) dose pack for discomfort in her knee, increase in swelling, knee is swollen; methylprednisolone (medrol) dose pack, ice for knee is slightly warm outcome: recovered for device malfunction, discomfort in her knee, increase in swelling, knee is swollen and knee is slightly warm; unknown for not feeling good.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.Seriousness criteria: required intervention for discomfort in her knee, increase in swelling, knee is swollen, knee is slightly warm and device malfunction pharmacovigilance comment: sanofi company comment dated 22-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced injection site discomfort, joint swelling, joint warmth.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: 7269202
• MDR Text Key: 100427747
• Report Number: 2246315-2018-00266
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• 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; Required Intervention
• Patient Age: 72 YR