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 Arthritis (1723)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This case is cross referred to (b)(4) (cluster).This unsolicited case from united states was received on 21-feb-2018 from a medical doctor and nurse.This case concerns a (b)(6) female patient who experienced septic arthritis/ infection of left knee (unknown latency), elevated wbc at 13.3 (02 days later), esr elevated at 85 (02 days later) and crp elevated at 24.7 (02 days later) after receiving treatment with synvisc one.Also device malfunction was identified for the reported lot number.Medical history included hypertension.Concurrent condition included chronic pain syndrome.Concomitant medications reported include tramadol hydrochloride (tramadol) for chronic pain, gabapentin for neuropathic pain, indometacin (indomethacin) for arthritis.The patient was allergic to oxycodone hydrochloride/ paracetamol (percocet) and codeine (vomiting/itching/ nausea) and tetanus toxoid (anaphylaxis).On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection 1 df once (batch/ lot number: 7rsl021, expiry date: not provided) for severe knee arthralgia injected to each knee.The same day, the patient experienced increased pain, stiffness, swelling and heat to the injected knee on left side.On (b)(6) 2017, the patient was taken to the o.R.By orthopedics for washout.The same day, white blood cell count was elevated 13.3, esr (erythrocyte sedimentation rate) was elevated 85, c-reactive protein was elevated 24.7 (units and reference range not provided) for all and the blood culture showed no growth.On an unspecified date in (b)(6) 2017 after unknown latency, the patient experienced septic arthritis/ infection of left knee.Corrective treatment: vancomycin, linezolid, piperacillin sodium/tazobactam sodium (zosyn), ciprofloxacin (cipro) and ceftriaxone sodium (rocephin) for septic arthritis/ infection of left knee; not reported for rest all the events outcome: not recovered for device malfunction and septic arthritis/ infection of left knee; unknown for rest 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction and septic arthritis/ infection of left knee reporter causality: yes for septic arthritis/ infection of left knee.Pharmacovigilance comment: sanofi company comment dated 02-mar-2018: this case concerns a patient who received treatment with synvisc one injection from the recalled lot and later experienced septic arthritis, knee pain, joint stiffness, knee swelling, joint warmth, knee effusion, wbc increased, esr increased and crp increased.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: 7326944
• MDR Text Key: 102318894
• Report Number: 2246315-2018-00363
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 99