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); Loss of Range of Motion (2032); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 21-feb-2018 from patient this case concerns (b)(6) female patient who initiated treatment with synvisc one and on the same day infection nos, could not bare weight on the right knee, knee was hot, drain fluid from the knee, knee swelling; after few days had pain in the right knee/ from a scale of 1 to 10, is a 8.5.Also, a device malfunction was noted for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.Patient had a history of arthritis for which she took hydroxychloroquine, methotrexate and folic acid on (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once knee osteoarthritis (batch/ lot number: 7rsl021 and expiry date: unknown) in right knee.On the same day, she experienced fever, chills, and could not bare weight on the right knee, knee was hot.Patient said the next day on (b)(6) 2017, she went to emergency room (er).Patient had to use crutches and wheelchair when she went to the emergency room because she could not walk.She said the physician examined her right knee and drain fluid from the knee.Physician prescribed cefdinir 300 mg to fight infection.Patient started feeling better on (b)(6) 2017 but still had a little pain in right knee.She said she only took advil-pm at night and did not take any other pain medications.Corrective treatment: had crutches to use and wheelchair for could not bare weight on the right knee; cefdinir for infection nos; ibuprofen (advil) for knee swelling and pain in the right knee/ from a scale of 1 to 10, is a 8.5 outcome: unknown for pain in the right knee/ from a scale of 1 to 10, is a 8.5; recovering for all events seriousness criteria: disability for device malfunction and could not bare weight on the right knee 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: 28-feb-2018: this case concerns a female patient who received treatment with synvisc one and later had infection nos, weight bearing difficulty, joint warmth, knee effusion and knee swelling.Based upon the temporal gap, the causal role of the product cannot be denied for the occurrence of event.Further as the device has been identified to have malfunction so the causal relationship of the events to the product 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: 7326926
• MDR Text Key: 102339531
• Report Number: 2246315-2018-00362
• 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
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/22/2018

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 Lot Number: 7RSL021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/09/2018
• 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): Disability
• Patient Age: 68 YR
• Patient Weight: 75