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 No Code Available (3191)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 24-jan-2018 from a patient.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and on the same day used a cane to get around/need to use a cane, temperature low grade around 99.2 degrees f, patient was not able to bear weight after the injection and had inflammation.Also device malfunction was identified for the reported lot number.Patient's medical history included osteoarthritis in left knee, sinus problems.No past drug and concurrent condition was provided.Patient had no prosthetic hip/ knee, prosthetic valve, pacemaker and or defibrillator.Patient was not receiving any concomitant medications.Patient was not allergic to avian proteins, feathers, or egg products.On an unknown date in (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided) in left knee for osteoarthritis in left knee.Patient's left knee area was disinfected, the physician used gloves to touch and felt where to give the injection, and after injection got off table while bracing on a stool.Betadine solution was prepared for disinfection.The package was open for less than a minute prior to injection.No other medications were injected into the knee joint at the same time as synvisc-one.Patient did not engage in activities such as jogging or tennis soon after the injection (prior to onset of symptoms).Prior to the injection, patient was able to bear weight just a little and with her knee brace, but after the injection patient could not and it hurted too bad on the same day.On the same day, patient started experiencing pain, inflammation and swelling in the left knee (left knee swelled up twice it's size).Patient's pain was 10 on pain scale and 10 being the worse pain and before the injection pain was 6 on pain scale.On the same day, patient had to use a cane to get around and had temperature low grade around 99.2 degrees f.Patient's physician told patient to use ice and elevation to the left knee.Patient was prescribed generic meloxicam (mobic) 15 mg daily for the pain.Swelling and pain increased during the next few weeks.Pain and swelling did not go and would not go away and after 5 weeks patient went back to her physician.Patient was told to stop meloxicam 3 weeks after the injection and started taking naproxen sodium (aleve) 200 mg 2 tablets in the morning and two tablet in the evening.It was reported that the swelling and pain went down.Patient's left knee was half the size and was noticed by her physician.The pain level was down to an 8.Patient was still on naproxen sodium as of (b)(6) 2018.Patient's swelling was still going down and pain level was going down to a 7 or 6.Patient had some sinus problem that might make her fever go up a little.Patient was advised to contact her healthcare provider for more synvisc-one injection if needed.Corrective treatment: cane for use a cane to get around/need to use a cane and ice and elevate, meloxicam, naproxen sodium for inflammation and not reported for temperature low grade around 99.2 degrees f, patient was not able to bear weight after the injection 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: disability for use a cane to get around/need to use a cane and device malfunction.Pharmacovigilance comment: sanofi company comment dated 31-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was unable to walk for which patient used cane.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: 7265942
• MDR Text Key: 100265209
• Report Number: 2246315-2018-00256
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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
• Date Manufacturer Received: 01/24/2018
• 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): Disability
• Patient Age: 43 YR
• Patient Weight: 98