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 Erythema (1840); Swelling (2091)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 12-dec-2017 from nurse.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after unknown latency her left knee was locked in extension, had thigh swelling, red left knee/ red thigh, swollen left knee and was unable to bend the left knee.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, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020) in each knee for osteoarthritis knee pain.On an unknown date in (b)(6) 2017, after unknown latency, the patient experienced an adverse reaction only in her left knee, consisting of a red and swollen left knee and thigh, and the left knee was locked in extension, and the patient was unable to bend the left knee.Also, device malfunction was identified for the reported lot number on an unknown date in (b)(6) 2017.Corrective treatment: not reported for all events.Outcome: not recovered for 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 12-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced joint lock, swelling of leg, joint range of motion, localized erythema and left 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 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: 7177796
• MDR Text Key: 97802984
• Report Number: 2246315-2017-00374
• 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: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• 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: 12/12/2017
• 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: 38 YR