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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Arthralgia (2355); No Code Available (3191)

Event Type  malfunction  

Event Description

Device malfunction [device malfunction]. Lot of pain/ left knee with mostly medial jlt [joint tenderness]. Mild effusion [joint effusion]. Case narrative: this case is linked to case (b)(4) (same patient). Initial information received on 02/07/2019 regarding an unsolicited legal valid serious case received from a patient. This case involves a (b)(6) years old male patient (185. 395 cm and (b)(6) kg) who experienced lot of pain/ left knee with mostly medial jlt and mild effusion, while he had treated with hylan g-f 20, sodium hyaluronate (synvisc one). Also, device malfunction was identified for the reported lot number. The patient's past medical history included atrial fibrillation, prostate cancer in 2004, aortic valve replacement in (b)(6)-2008, thyroidectomy in 1973, retinopexy, nasal polyps, alcohol use, lactose intolerance with diarrhea and abdominal pain, rubber sensitivity on (b)(6)-2015, dermatitis contact, hematuria, bronchitis, prostatitis, chest pain, urinary tract infection, anemia, urinary tract obstruction, cough and asthenia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing erectile dysfunction and hypersensitivity. Concomitant medications included paracetamol (tylenol); amlodipine besilate (norvasc); ciprofloxacin (cipro); doxycycline; diazepam (valium); fluticasone propionate (flonase) finasteride (proscar); levofloxacin (levaquin); levothyroxine sodium (synthroid); lorazepam (ativan); tamsulosin hydrochloride (flomax); prednisone; and warfarin sodium (coumadin), acetylsalicylic acid (aspirin), celecoxib (celexa). Olopatadine hydrochloride (pataday), cyanocobalamin (vitamin b12). On (b)(6)2017, the patient started taking synvisc one (hylan g-f 20, sodium hyaluronate), injection, 48 mg once via intra-articular route (lot - 7rsl021) for osteoarthritis and arthritis. On the next day, the patient developed a non-serious lot of pain/ left knee with mostly medial jlt (arthralgia) <> following the first dose intake of hylan g-f 20 and sodium hyaluronate. On an unknown date, the patient developed a non-serious mild effusion (joint effusion) following the first dose intake of hylan g-f 20 and sodium hyaluronate. Also, device malfunction was identified for the reported lot number of hylan g-f 20 and sodium hyaluronate. Relevant laboratory test results included: x-ray limb - on an unknown date: [minor loss of medial compartment joint space. The joints are otherwise well aligned. ] final diagnosis was severe lot of pain/ left knee with mostly medial jlt, mild effusion and device malfunction. It was not reported if the patient received a corrective treatment. Outcome- unknown for all 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 was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Seriousness criteria- medically significant for device malfunction.

• 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: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8352559
• MDR Text Key: 140291818
• Report Number: 2246315-2019-00063
• 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,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 02/19/2019 Patient Sequence Number: 1