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 Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 11/29/2017

Event Type  malfunction  

Event Description

Based on additional information received on 19-dec- 2017, this case initially considered as non-serious was upgraded to serious due to the event of device malfunction with seriousness criteria of important medical event.(b)(4).This unsolicited case from united states was received on 05-dec-2017 from an other non-health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after 7 days had pain, swelling and was aspirated.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020; dose: not provided) in right knee for osteoarthritis.Patient returned to the office on (b)(6) 2017 reporting pain and swelling.On the same day, patient also had knee effusion.It was the patient's first series.The practitioner aspirated and recommended ice and elevation.It was assumed that the patient was doing better because they did not heard back.Corrective treatment: aspiration, ice, elevation for all events.Outcome: recovering for all events.Seriousness criteria: of important medical event.(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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Additional information was received on 19-dec-2017.Event of device malfunction was added.Case became serious.Seriousness criteria was added.Ptc (pharmaceutical technical complaint) results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 19-dec-17: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced right knee effusion , knee pain and knee 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: 7345512
• MDR Text Key: 103170110
• Report Number: 2246315-2018-00400
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• 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
• Patient Age: 61 YR