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 Inflammation (1932); Reaction (2414)

Event Date 11/22/2017

Event Type  malfunction  

Event Description

Based on the information received on 22-nov-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This case was cross referenced with cases: (b)(4) (cluster).This unsolicited case from united states was received on 22-nov-2017 from a other non-healthcare professional this case concerns patient (age and gender unspecified) who received treatment with synvisc one and on the same day had "flare up," or an inflammatory reaction of some type/severe localized reactions in the knee joint.No medical history, past drugs, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, once (dose, indication, batch/lot number: 7rsl021 and expiry date: 31-may-2020).On the same day, another patient at their practice had experienced a flare-up/inflammatory reaction from synvisc-one.Patient had severe localized reactions in the knee joint.The personnel in the practice did not know how soon after the synvisc-one was injected that these inflammatory reactions had occurred.Corrective treatment: not reported outcome: unknown.Seriousness criteria: important medical event for device malfunction.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).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.Additional information was received on 05-dec-2017.Product lot number and expiration date was added.The as reported term for event was updated from "flare up," or an inflammatory reaction of some type to "flare up," or an inflammatory reaction of some type/severe localized reactions in the knee joint.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-nov-2017.Global ptc number and ptc results were added.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly pharmacovigilance comment: sanofi follow-up company comment dated 22-nov-2017: this case concerns a patient who received treatment with synvisc one and later experienced joint inflammation.A temporal relationship can be established with the product administration.Also, the concerned lot number has been identified to have malfunction by the company.Thus, 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: 7142594
• MDR Text Key: 96240253
• Report Number: 2246315-2017-00354
• Device Sequence Number: 0
• Product Code: MOZ
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/22/2017

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: Physician
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/22/2017
• 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