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 Joint Swelling (2356); Joint Disorder (2373)

Event Date 11/14/2017

Event Type  Injury  

Event Description

This case was cross reference with case id: (b)(4) (cluster) this unsolicited case from united states was received on (b)(6) 2018 from the physician.This case concerns (b)(6) year old female patient who received treatment with synvisc one injection and on the same day had knee joint effusion and knee joint pain.Also, device malfunction was identified for the reported lot number.No relevant medical history, past medications and concomitant medications were reported.On (b)(6) 2017, at 02:45 pm, patient was injected with 1cc of 1 % lidocaine and received treatment with intraarticular synvisc one injection at a dose of 6 ml once (expiration date: may-2020; lot number: 7rsl021) for knee osteoarthritis.On the same day after receiving the injection, patient had knee joint effusion and knee joint pain.It was reported that patient was brought back to aspirate the effusion, injected the joint with steroid and was fluid was sent for analysis.On (b)(6) 2017, patient recovered from both the events.It was reported that the patient has reaction to product.Corrective treatment: steroid (unspecified) for knee joint pain and knee joint effusion; not reported for device malfunction outcome: 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 was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness criterion: required intervention for all events pharmacovigilance comment: sanofi company comment dated (b)(6) 2018.This case concerns a patient who presented with knee pain and effusion after receiving treatment with synvisc one.Based upon the information, a significant temporal relationship can be established between the injection and the occurrence of events.Further, as the concerned lot number has been identified to have malfunction by the company, so a causal role of the drug for the occurence of the events 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: 7334481
• MDR Text Key: 102249141
• Report Number: 2246315-2018-00396
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 02/27/2018
• 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): Required Intervention
• Patient Age: 72 YR