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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Arthralgia (2355); Joint Swelling (2356)
Event Date 11/01/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 21-mar-2018 from the other health care professional. This case involves a patient (unknown gender) who received treatment with synvisc one and after few hours the patient had severe pain, swelling and device malfunction was identified for the reported lot number. No medical history, past drugs, concomitant medications, concurrent condition was provided. On unknown date of (b)(6) 2017, the patient initiated treatment with injection of synvisc one, intraarticular at a dose of 6 ml (frequency: once; lot number: 7rsl021) for unilateral primary osteoarthritis. On (b)(6) 2017, after few hours the patient had severe pain, swelling. Corrective treatment: not reported. Outcome: unknown 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 was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Seriousness criteria: medically significant. Pharmacovigilance comment: sanofi company comment dated 21-march-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced 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.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-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 Key7402621
MDR Text Key105265557
Report Number2246315-2018-00432
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2018 Patient Sequence Number: 1
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