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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, 7RSL022
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Bacterial Infection (1735); Arthralgia (2355); Joint Swelling (2356)
Event Date 12/07/2017
Event Type  malfunction  
Event Description
Based on additional information received on 23-feb-2018 from health care professional, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added. This case is cross referred with the (b)(4) (cluster). This unsolicited case from united states was received on 28-dec-2017 from health care professional. This case concerns a female patient (age not provided) who received treatment with synvisc one injection and after 1 day left knee red, left knee hot, left knee pain/left knee tender, anterior portion of left knee continued to become more swollen and after 2 days, had infections/ methylobacterium species in sterile body fluid culture. Also device malfunction was identified for the reported lot number. No past drug, concomitant medication and concurrent condition was provided. The concomitant medications included lidocaine (local anesthetic). On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection (batch/lot number: 7rsl021 and 7rsl022; expiration date: may-2020 for both) (bilateral knee joint injections) at a dose of 6 ml once for knee pain. On (b)(6) 2017, (latency 1 day), the patient had left knee pain that began in the left posterior region and had spread to the superior portion of left calf. The same day, the anterior portion of left knee continued to become more swollen, red, hot and tender at night. The patient was advised to come to ed (arthroscopic irrigation and debridement on second ed visit with admission). On (b)(6) 2017, sterile body fluid culture aerobic was abnormal (methylobacterium spp). On an unknown date, after unknown latency, patient had infections. Corrective treatment: arthroscopic irrigation and debridement for left knee red, left knee hot, left knee pain/left knee tender and anterior portion of left knee continued to become more swollen outcome: unknown for have infections and have infections/ methylobacterium species in sterile body fluid culture; recovered for rest of the 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 would be completed, corrective and preventive actions would be implemented. Seriousness criteria: important medical event for have infections/ methylobacterium species in sterile body fluid culture; required intervention for device malfunction, left knee red, left knee hot, left knee pain/left knee tender and anterior portion of left knee continued to become more swollen additional information was received on 23-feb-2018 from health care professional. This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added. The event term was updated from infections to have infections/ methylobacterium species in sterile body fluid culture (ime). The suspect product batch/lot number, expiry date, dose, frequency and indication were added. The additional events of left knee red, hot, tender, left knee pain, left knee pain that began in the left posterior region and has spread to the superior portion of left calf and left knee swollen were added with details. The patient's concomitant medication was added. Clinical course updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 28-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced methylobacterium infection, joint warmth,injection site joint redness 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 Key7331169
MDR Text Key102350101
Report Number2246315-2018-00369
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7RSL021, 7RSL022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/12/2018 Patient Sequence Number: 1
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