MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Arthritis (1723); Fever (1858); Unspecified Infection (1930); Arthralgia (2355); No Code Available (3191)

Event Date 11/10/2017

Event Type  Injury  

Event Description

Device malfunction [device malfunction]; suspected septic arthritis [septic arthritis]; fever [fever] ; pain in unspecified knee/right knee pain [knee pain].Case narrative: initial information received on 03-apr-2019 from united states regarding an unsolicited valid legal serious case received from a lawyer.This case involves a (b)(6) years old female patient who experienced suspected septic arthritis (latency: same day), fever (latency: same day) and pain in unspecified knee/right knee pain (latency: same day), while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added for the identified lot number.The patient's past medical history included hypercholesterolaemia, allergic rhinitis, appendicectomy, gastrooesophageal reflux disease without esophagitis and rotator cuff surgery.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included naproxen; hydrocodone bitartrate, paracetamol (hydrocodone/acetaminophen); celecoxib; esomeprazole; montelukast; salbutamol sulfate (ventolin hfa); budesonide, formoterol fumarate (symbicort); and atorvastatin.On (b)(6) 2017, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at 6ml once (indication: unknown) (lot - 7rsl021, may 2020).On the same day, patient was admitted to the hospital because of right knee pain (latency: same day) and was suspected of septic arthritis (latency: same day) but no growth in the culture was noted.The patient also had fever (latency: same day).On (b)(6) 2017, patient was discharged from the hospital in fair condition without antibiotic treatment and was instructed to follow up after a week and was advised to take a low salt and low fat diet.Corrective treatment: not reported.Outcome: unknown for all events.Seriousness criterion: medically significant for septic arthritis; hospitalization for septic arthritis, fever and right knee pain.An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8542670
• MDR Text Key: 142898892
• Report Number: 2246315-2019-00124
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN (ATORVASTATIN),TABLET; CELECOXIB (CELECOXIB), CAPSULE; ESOMEPRAZOLE (ESOMEPRAZOLE),CAPSULE; HYDROCODONE/ACETAMINOPHEN,TABLET; MONTELUKAST (MONTELUKAST),TABLET; NAPROXEN (NAPROXEN), TABLET; SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE),UNKNOW; VENTOLIN HFA (SALBUTAMOL SULFATE),UNKNOWN
• Patient Outcome(s): Hospitalization; Other; Required Intervention