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 Headache (1880); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

Based on the information received on 06-feb-2018, the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This spontaneous case from united states was received on 03-jan-2018 from the patient.This case concerns (b)(6) female patient who initiated treatment with synvisc one and on the same day had headache, could not put any pressure on right leg, chills, body aches, knee swelled/severe swelling in right knee; after few hours had high fever of 102; after unknown latency unable to walk, couldn't bend knee, pain in knee.Also, device malfunction was identified for the reported lot number.Patient had previously received synvisc one.Patient had gerd (gastroesophageal reflux disease), migraines, fibromyalgia and osteoarthritis.Concomitant medications include omeprazole (prilosec) for gerd, ibuprofen for fibromyalgia and sumatriptan (imitrex) for migraine.Patient had allergy to adhesives.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once, for osteoarthritis (batch/ lot number : 7rsl021; dose and expiry date: unknown).On the same day at probably midnight she woke up with fever.On the same day, patient had severe swelling in right knee, had headache, could not put any pressure on right leg.She stated that the day after she received it her knee swelled pretty significantly, she had a very high fever of 102, and she was unable to walk for 4 days because she couldn't bend her knee at all.She stated that she had chills, body aches, swelling and stiffness after she received the synvisc-one and she still has pretty significant pain in her knee.She stated that she hasn't had any relief nor has she had any treatment.Patient had lab test on (b)(6) 2018, and no bacteria was noted.Corrective treatment: naproxen sodium (aleve) for headache, body aches, could not put any pressure on right leg, high fever of 102; naproxen sodium (aleve), diphenhydramine hydrochloride (benadryl) for chills; none for unable to walk, couldn't bend knee, stiffness, pain in knee, knee swelled/severe swelling in right knee.Outcome: recovered for headache, could not put any pressure on right leg, high fever of 102, chills, body aches, knee swelled/severe swelling in right knee; not recovered for rest 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.Follow up was received on 16-jan-2018.No new information received.Additional information was received on 06-feb-2018.This case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.Medical history and concomitant medications added.Events of headache and could not put any pressure on right leg were added along with its details.Clinical course updated.Text was amended accordingly pharmacovigilance comment: sanofi company comment dated 06-feb-2018: this case concerns a patient who suffered from headache, weight bearing difficulty, fever, unable to walk, joint range of motion decreased, chills, body aches, right knee stiffness, pain in knee and right knee swelling after receiving synvisc one injection from the recalled lot.Temporal relationship can 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: 7284997
• MDR Text Key: 100924372
• Report Number: 2246315-2018-00321
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• 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: 02/06/2018
• 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: 40 YR
• Patient Weight: 122