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 Pain (1994); Swelling (2091); Fluid Discharge (2686)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

Based on the information received on 23-jan-2018, the case became medically confirmed.The case was updated to serious due to addition of event of device malfunction.This unsolicited case from united states was received on 07-dec-2017 from the other non-health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and on the same day had pain began that night/continued pain; after an unknown latency had throbbing swelling left knee and knee was eventually aspirated.Also, device malfunction was identified for the reported lot number.No relevant medical history, past medications and concomitant medications were reported.Concomitant medications included: atorvastatin, ibuprofen, valsartan, acetylsalicylic acid (aspirin) and tramadol hydrochloride (tramadol).History: high blood pressure, thyroid disorder, wears glasses, osteoarthritis, hysterectomy, right and left hip replacement on (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at the dose of 6 ml, once (lot number 7rsl021 and expiration date: may- 2020) for knee osteoarthritis.On the same day patient had pain began that night/continued pain.On (b)(6) 2017, patient went to emergency room.On an unknown date, the knee was eventually aspirated in physician's office.On an unknown date, after unknown latency the patient had throbbing swelling.Corrective treatment: knee was eventually aspirated for throbbing swelling left knee; not reported for others outcome: recovered for all a pharmaceutical technical complaint (ptc) was initiated with global (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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction additional information was received on 03-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 23-jan-2018.Event of device malfunction and pain began that night/continued pain was added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 23-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee swelling, knee effusion and knee pain.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: 7272517
• MDR Text Key: 100471492
• Report Number: 2246315-2018-00284
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/15/2018
• 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): Other
• Patient Age: 75 YR