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

Lot Number 7RSL021, 7RSL019

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Arthritis (1723); Bacterial Infection (1735); Pain (1994)

Event Date 11/29/2017

Event Type  malfunction  

Event Description

(b)(4) this spontaneous case from united states was received on 08-dec-2017 from nurse. This case concerns a (b)(6) male patient who initiated treatment with synvisc one and after 2 days had 100 degree temp, stomach issues and excessive soreness, also, device malfunction was identified for the reported lot number. No medical history, previous medications, concomitant medications and concurrent conditions were reported. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for right knee arthritis (batch number: 7rsl021; expiry date: unknown). On (b)(6) 2017, after a latency of 2 days, patient was complaining of excessive soreness; he also said that he had a 100 degree temp with stomach issues. Corrective treatment: not reported for all events. Outcome: not recovered for all events. Seriousness criteria: important medical event for device malfunction. 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. Pharmacovigilance comment: sanofi company comment dated 08-jan-2017: this case concerns a male patient who received synvisc one injection from the recalled lot for left knee arthritis and later experienced excessive soreness, stomach issues and 100 degree temperatuure. 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: 7178473
• MDR Text Key: 97861512
• Report Number: 2246315-2018-00086
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: Other
• Device Lot Number: 7RSL021, 7RSL019
• 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 Received: 04/09/2018
• 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: 01/10/2018 Patient Sequence Number: 1