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 Pain (1994); Swelling (2091); Reaction, Injection Site (2442)

Event Date 11/14/2017

Event Type  malfunction  

Event Description

This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 07-feb-2018 from a healthcare professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and the same day the patient had increased knee pain and knee swelling; also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.Patient had no known drug allergies (nkda).On (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection, at the dose of 6 ml, once (batch/lot number: 7rsl021; expiry date: may-2020) for osteoarthritis bilateral.The same day, the patient had increased knee pain and swelling.Corrective treatment: not reported for all.Outcome: recovered for all.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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment for follow up dated 16-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had increased knee pain and swelling.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: 7285289
• MDR Text Key: 100905606
• Report Number: 2246315-2018-00326
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/07/2018

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: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• 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: 62 YR