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 Problem No Code Available (3191)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

This case has been cross referred with case id (b)(4) (cluster).This unsolicited from united states was received on 29- jan-2018 from the nurse.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and on the same day, developed pseudo sepsis and 1 day later had synovial fluid analysis abnormal.Also, device malfunction was identified for the reported lot number.Patient's concurrent condition included osteoarthritis of right knee.Patient's concomitant medication included levothyroxine sodium (levothyroxine), atenolol, levothyroxine sodium (synthroid) and tramadol hydrochloride (tramadol).Patient had allergy to penicillin and hydrocodone bitartrate/paracetamol (lortab).On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (lot number 7rsl021 and expiration date: may-2020).On the same day, patient experienced, severe pain, swelling in the evening after the shot.On (b)(6) 2017, 1 day after the synvisc one injection, patient was seen in the doctor's office and 100cc of slightly cloudy fluid was effused.It was reported that the patient was diagnosed with pseudo sepsis reaction.Corrective treatment: 100 cc knee effusion slightly cloudy fluid withdrawn for pseudo sepsis.Outcome: not recovered/not resolved for all the events.A pharmaceutical technical complaint (ptc) was initiated and results were pending reported causality: events were related to sanofi-aventis product: yes seriousness criteria: important medical event for the event of device malfunction pharmacovigilance comment: sanofi company comment dated 5-feb-2018.This case concerns four patients who has received synvisc one injection from the recalled lot and later experienced pseudo sepsis.Since the events occured post administration of synviscone, 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 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: 7296085
• MDR Text Key: 101379484
• Report Number: 2246315-2018-00288
• 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

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 01/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR