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)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

This case is cross-referred to cases: (b)(4) (same reporter).This unsolicited case from united states was received on 29-jan-2018 from a healthcare professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and later after on the same day developed severe pain, swelling evening after injections and after 4 days aspirated knee-55ccdark/serous,yellow fluid and patient had exposure during pregnancy.Also, device malfunction was identified for the reported lot number.Patient was allergic to pregabalin (lyrica), pyritinol hydrochloride (neuroxin), phentermine/topiramate (qsymia), valproate semisodium (depakote) venlafaxine hydrochloride (effexor).Concomitant medications included cyanocobalamin (vitamin b12), calcium/ cholecalciferol (calcium d), pantoprazole sodium (protonix), omeprazole (prilosec) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/ dexamfetamine sulfate (adderall).Patient had a history of osteoarthritis right knee.No relevant concurrent conditions were reported.On (b)(6) 2017, the patient initiated treatment with intra- articular synvisc one injection once (dose: not provided; batch/lot: 7rl2021 and expiration date: may- 2020) for osteoarthritis right knee.On the same day, patient developed severe pain and swelling evening after injections.Patient went to emergency room (er) and was given pain medication and crutches.On (b)(6) 2017, patient was seen back in the office aspirated knee-55ccdark/serous,yellow fluid.It was sent for the labs.On same day, the patient's synovial fluid cell count, culture and synovial fluid crystal were negative.Corrective treatment: er, pain meds and crutches for develop severe pain, swelling evening after injections; not reported for aspirated knee-55ccdark/serous,yellow fluid outcome: recovered/ resolved for all the events seriousness criteria: disability for device malfunction, develop severe pain and swelling evening after injections reporter causality description: related a pharmaceutical technical complaint (ptc) was initiated.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 would be completed, corrective and preventive actions would be implemented.Pharmacovigilance comment: sanofi company comment dated 06-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and experienced severe pain, swelling and aspirated knee with dark, serous yellow fluid.The events are temporally related to device.Moreover, 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: 7275983
• MDR Text Key: 100533136
• Report Number: 2246315-2018-00290
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/29/2018

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: 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
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/16/2018
• 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: 44 YR