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); Reaction, Injection Site (2442)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 06-feb-2018 from other non-health care professional.This case concerns a female patient (age unspecified) who received treatment with synvisc one and after an unknown latency patient had pressure on right knee and painful behind knee when flexing/extreme pain.Also, device malfunction was identified for the reported lot number.No past drugs, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra articular synvisc one injection (lot number: 7rsl021; dose, frequency, indication and expiration date: not reported) in right knee bilaterally.On an unknown date, latency unknown, patient was painful behind knee when flexing, extreme pain and pressure on right knee.Patient went to er (emergency room) when traveling back home, ultrasound was done to rule out dvt (deep vein thrombosis), patient was given flexeril and tramadol.Patient did state that the knee was not hot or red.Patient traveled back to clinic in mid (b)(6) where the knee was aspirated with no evidence of infection, and cultures were negative.Corrective treatment: not reported for device malfunction; cyclobenzaprine hydrochloride (flexeril) and tramadol hydrochloride (tramadol) for painful behind knee when flexing/extreme pain and pressure on right knee.Outcome: unknown for all 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 9-feb-18.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain upon movement and sensation of pressure.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out 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: 7279833
• MDR Text Key: 100667591
• Report Number: 2246315-2018-00318
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2018
• 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