MAUDE Adverse Event Report: TEDEC-MEIJI FARMA GENVISC 850; ACID, HYALURONIC, INTRAARTICULAR

Model Number	50653-0006-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Arthralgia (2355)
Date of Event	10/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sterility testing of lot n-5 at production confirms sterility of lot n-5.Note: batch identification correlation: consecutive batch manufactured per year = sap inspection batch number (insp) = to final product lot number.L7/l9: insp: (b)(4): lot n-5.(b)(4).
Event or Problem Description
The health care provider (hcp) reported to ae assessor that after the 4th bilateral knee injection on (b)(6) 2019 the patient was hospitalized for bilateral septic knee joints.The medical history of the patient includes osteoarthritis, bariatric surgery, back problems requiring occasional use of a cane and hypertension managed with lisinopril.On (b)(6) 2019 the patient started the weekly genvisc850 bilateral knee injection series which were improving the knee discomfort.On (b)(6) 2019 the patient received the 4th bilateral knee injection.On (b)(6) 2019 the patient was not getting pain relief in his left knee so he went to the orthopedic urgent care and x-rays were performed, gout was diagnosed and prednisone was prescribed.On (b)(6) 2019 the patient went to the emergency room for discomfort in his knees bilateral.The er was going to send the patient home when the patient insisted something was wrong.They tapped the patients knees with results of wbcs >70,000 in the left knee and >40,000 in the right knee.The patient was admitted to the hospital on (b)(6) 2019, sent to surgery and his knee joints were washed out.A picc line was inserted and a six week course of antibiotics was initiated.Anticipated hospital discharge date is unknown at this time.Ae assessor spoke to the hcp on (b)(6) 2019 which was after the hospitalization and the hcp had no updated information regarding the patient.Since the hcp was not willing to share the patients contact information the ae assessor has no farther information of the patients status.The hcp procedure for providing genvisc 850 injections is to inject contrast from a multi-use vial for fluoroscopy to identify the site in the joint for a genvisc 850 injection and to provide an injection of lidocaine from a multi-use vial to decrease the discomfort.This complaint will be considered serious due to the patient requiring medical intervention for a diagnosis of bilateral septic knees.On oct 30, 2019 the manufacturer's qc team reported that the result of the sterility test of the batch n-5 of genvisc850 is sterile which was used in the 4th bilateral knee injection for the patient.The potential contributing factors outside the temporal relationship of the genvisc 850 injection include the multi-use vials of contrast and lidocaine used by the hcp.Location of the multi-use vials is unknown by the ae assessor.This case is being closed as serious due to septic knee joints requiring hospitalization for surgery and iv antibiotics.Likely contributing factors are the multi-use vials of contrast and lidocaine used by the hcp in the knee injection.The genvisc850 knee injection was from a sterile batch of lot n-5 but the genvisc 850 cannot be ruled out due to the temporal relationship.

• Brand Name: GENVISC 850
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): TEDEC-MEIJI FARMA; ctra. m-300, km 30, 500-28802; alcala de henares (madrid), ; SP
• MDR Report Key: 9354450
• Report Number: 3003184440-2019-00003
• Device Sequence Number: 2790037
• Product Code: MOZ
• UDI-Device Identifier: 00850653006016
• UDI-Public: (01)00850653006016(17)220731(10)N5
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P140005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/25/2019
• Report Date (Section F): 11/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 50653-0006-01
• Device Lot Number: N-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2019
• Device Age: 3 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 11/21/2019