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

Model Number	50653-0006-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Joint Swelling (2356)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspect medical device, genvisc 850 sodium hyaluronate (ha) 10 mg/ml with a (b)(4), was manufactured, tested and released by (b)(4) according to fda approved processes and specifications.(b)(4), as part of the release of the product to the us market and additionally when evaluating this case, reviewed product components-release documentation (e.G.Bulk ha and syringe primary package, among others) as well as manufacturing batch records, product testing, and release documentation.In addition, as part the device design shipping study protocol, upon product arrival to the warehouse, in tennessee usa, genvisc 850 was retested for ha content and for sterility.Through out these series of evaluations, genvisc 850 complied with all the requirements of sterility, ha content as well as all the other specification required for release of the product to the us market.No findings were observed that would indicate that there is and issue with the suspect medical device in relation to product manufacturing process and release compliance.
Event or Problem Description
Clinic reported to ae assessor that pt.Had immediate swelling of knee with first genvisc 850 injection in the knee.Ae assessor spoke with the clinic operations supervisor for further investigation of this report.Pt.Presented to clinic on (b)(6) 2016 with bilateral knee pain, rated 6/10, with left > right and past medical history of left knee surgery in 1965 for a football injury.Clinic reports existing evidence of surgical scars and wires around the left patella.Bilateral genvisc 850 injections given on (b)(6) 2016 for diagnosis of knee pain and bilateral synovitis.Pt.Returned to the clinic on (b)(6) 2016 and the right knee was swollen; no redness or warmth noted.It was not documented in the chart that the swelling resulted immediately after the genvisc 850 injection.Right knee pain was rated 1/10 and 60 cc of clear yellow fluid was aspirated from the right knee with a toradol injection given into the right knee.On (b)(6) 2016 the pt.Returned to the clinic for follow-up and a right knee ultrasound showed moderate effusion; right knee aspirate done with 25 cc of clear yellow fluid aspirated - no pain indicated in the chart.On (b)(6) 2016 left knee genvisc 850 given for pain 1/10.Right knee pain and swelling resolved and pt.Only continued with genvisc 850 to the left knee.Pt.Had remaining left knee genvisc 850 injections on (b)(6) 2016; clinic noted the injections were tolerated well and pain at the end of the series was 0/10.Pt.Only remaining symptom at the end of the genvisc 850 series was left knee crepitus; right and left knee pain improved.Pt.Did develop right knee swelling/effusion x 2 after first genvisc 850 injection.Although pt.Had existing bilateral knee pathology, genvisc 850 injection cannot be excluded as a contributory factor to the swelling.The right knee swelling/ effusion resolved and there was no evidence of infection.This case will be closed without further follow-up from the ae assessor.The case will be closed as serious due to the reported effusion which required intervention.Based upon the information provided there is no remedial action required.

• Brand Name: GENVISC 850
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): TEDEC-MEIJI FARMA; ctra. m-300, km 30, 500; alcala de henares (madrid), 28802 ; SP 28802
• MDR Report Key: 6231869
• Report Number: 3003184440-2017-00003
• Device Sequence Number: 784767
• Product Code: MOZ
• UDI-Device Identifier: 00850653006016
• UDI-Public: (01)00850653006016(17)180630(10)J1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P140005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2016
• Report Date (Section F): 01/07/2017

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: 06/30/2018
• Device Model Number: 50653-0006-01
• Device Lot Number: J1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2016
• Device Age: 1 HR
• Event Location: Home
• Date Report to Manufacturer: 10/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 01/07/2017
• 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: Required Intervention
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/07/2017