MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problems Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Skin Inflammation (2443); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 11/08/2017

Event Type  malfunction  

Event Description

This case was cross referred with case: (b)(4) (cluster) this spontaneous case from united states was received on 18-jan-2018 from healthcare professional this case concerns (b)(6) male patient who initiated treatment with synvisc one and on the same day had pseudoseptic reaction, unable to sleep; after an unknown latency had antalgic gait, also, device malfunction was identified for the reported lot number.No previous medications and concurrent conditions were reported.Concomitant medications included: methotrexate, lysine (l-lysine) and simvastatin.Medical history included: right knee sprain, osteoarthritis and closed fracture of right distal fibula.Patient's knee was aspirated and cortisone was injected before he got a synvisc one shot.No known drug allergies, environmental allergies, contrast dye allergy or food allergies.Patient was a non-smoker and drinks rarely.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once at a diose of 6 ml (indication: unknown; batch/ lot number: 7rsl021 and expiry date: unknown).He stated that within few hours his knee swelled painful (sharp pain and worsening) and reported some chills.This did not improve with ice and ibuprofen.Patient was also unable to sleep the same day.Patient was in distress secondary to pain.Patient was using crutches.Patient had restricted weight bearing ability.On inspection the right knee had varus deformity and large swelling effusion, was tense, had some warmth.Patient reported he did not have any fever but had some chills last night.Range of motion was decreased with decreased flexion and decreased extension.On (b)(6) 2017, the knee was drained (90cc fluid).The fluid was brownish yellowish thick purulent.X-ray showed advanced tricompartmental osteoarthritis of knee with varus.On (b)(6) 2017, knee was drained again.The fluid was straw colored.The patient had joint complaint and swelling.On (b)(6) 2017, patient went to the healthcare professional with complain of knee pain.Patient denied any numbness or tingling.Tenderness is maximal medical medial joint line.On the same day, patient had a typical antalgic gait.There were no stretch signs.Corrective treatment: methylprednisolone, gentamycin, depo-medrol, lidocaine, doxycycline, indocin, doxycycline hyclate, indomethacin, oxycodone, ice, elevation, crutches; not reported for other events outcome: not recovered for all events seriousness criteria: required intervention and disability for pseudoseptic reaction and device malfunction 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.Pharmacovigilance comment: sanofi company comment dated 02-feb-2018: this case concerns a patient who received synvisc one injection from the recalled lot and had pseudoseptic reaction in right knee.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: 7262735
• MDR Text Key: 100263241
• Report Number: 2246315-2018-00274
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• 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: 01/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 93