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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problem Fluid Discharge (2686)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

Based on additional information received on 22-nov- 2017, this case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.(b)(4).This unsolicited case from united states was received on 20-nov-2017 from the nurse.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after unknown latency the patient had injection fluid build in both knees.Also, device malfunction was identified for the reported lot number.No relevant medical history and concomitant medications were reported.The patient had received synvisc one at least twice prior to the injection on (b)(6) 2017.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (dose, indication, lot number: 7rsl021 and expiration date: may-2020) in both the knees.On an unknown date in (b)(6) 2017, unknown latency of receiving the injection the patient had injection fluid build in both knees.They drew 80 cc of blood tinged, yellow and cloudy fluid from the knee which they sent for culture.Corrective treatment: drew 80 cc of fluid from the knee for injection fluid build in both knees; not reported.For device malfunction.Outcome: unknown for both events.(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 was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction additional information was received on 20-nov-2017.Related case id ((b)(4)) was added.Text amended accordingly.Additional information was received on 22-nov-2017.This case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.Event of device malfunction was added.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow-up dated 22-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee effusion.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: 7143766
• MDR Text Key: 96235218
• Report Number: 2246315-2017-00308
• Device Sequence Number: 0
• Product Code: MOZ
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• 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: 11/22/2017
• 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: 63 YR