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)

Event Type  malfunction  

Event Description

Based on additional information received on 28-mar- 2018, this case initially processed as non-serious was upgraded to serious as important medical event of device malfunction was added.This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 14-dec-2017 from the nurse.This case concerns a patient (age and gender unspecified) who received treatment with synvisc one and after unknown latency had pain and swelling.In this case event of device malfunction was also identified.No medical history, past drug, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular 6 ml once of synvisc one injection (indication: unknown) (batch/lot number: 7rsl021 and expiry date: may-2020).On an unknown date, (after unknown latency), patient was said to have pain and swelling.Corrective treatment: not reported for all events outcome: unknown for all events.Seriousness criteria: important medical event for device malfunction a pharmaceutical technical complaint (ptc) was initiated with (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.Follow-up information was received on 21-dec-2017.No new information was received additional information was received on 23-jan-2018.Global ptc number and results were added.Expiry date of synvisc one was added.Clinical course was updated and text was amended accordingly.Follow-up information was received on 13-mar-2018.No new information was received.Follow-up information was received on 15-mar-2018.No new information was received additional information was received on 28-mar-2018 from a nurse.Lot number was updated.Additional event of device malfunction was added.Case became serious.Clinical course was updated.Text was amended accordingly.

• 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: 7403522
• MDR Text Key: 105256818
• Report Number: 2246315-2018-00443
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 03/28/2018
• 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