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

Lot Number J1

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Arthralgia (2355); Joint Swelling (2356)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

Suspect medical device, genvisc 850 sodium hyaluronate (ha) 10 mg/ml with a (b)(4), was manufactured, tested and released by tedec-meiji farma 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 (b)(4), 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 Description

Provider clinic reported to orthogenrx that after the 5th genvisc 850 injection in the right knee, pt.Had intense pain and swelling in right knee along with right lower leg swelling.Ae assessor spoke with the clinic for further investigation of this report.Pt.Has a history of multiple series of hyalgan injections for osteoarthritis (oa).Pt.Was started on bilateral genvisc 850 injections on (b)(6) 2016 for pain rated 7 to 8 out of 10, exacerbated with any activity; left knee pain > the right knee pain.Pt.Was also on celebrex for knee pain.Genvisc 850 injections ended (b)(6) 2016.Clinic states that pt.Presented to the clinic on (b)(6) 2016 for "extreme pain" with "swelling in joint and distal joint line tenderness".Ultrasound was performed on (b)(6) 2016 and showed a "large baker's cyst with possible vascular compression causing swelling"; pt.Was also sent to the emergency room to rule out a dvt.Pt.Has not returned to the clinic for follow-up and final report regarding the possible dvt was not available.A baker's cyst is typically caused when excess joint fluid is pushed into one of the small sacs of tissue behind the knee.The sac can fill with fluid and protrude out, resulting in a cyst.A baker's cyst in the knee may result from rheumatoid arthritis, osteoarthritis (oa) or direct knee trauma.The source of the "extreme" pain and swelling one week after the 5th genvisc 850 injection is likely related to the baker's cyst and possible dvt, however the ae assessor cannot exclude the possibility that the genvisc 850 injection into the right knee may have exacerbated symptoms.This case will be closed without further follow-up from the ae assessor.The ae assessor will close the case at this time with a follow-up call to the clinic in one month, to determine if additional information is available.The case will be closed as serious as the pt.Was sent to the emergency room for evaluation and possible treatment.The case is limited in investigations without the emergency room records/diagnostics being available for review.

• Brand Name: GENVISC 850
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): TEDEC-MEIJI FARMA; ctra. m-300, km 30, 500; alcala de henares (madrid), 28802 ; SP 28802
• Manufacturer (Section G): TEDEC-MEIJI FARMA; ctra. m-300, km 30,500; alcala de henares, madrid 28802 ; SP 28802
• Manufacturer Contact: celia vazquez lopez ; ctra. m-300, km 30, 500; alcala de henares, madrid 28802 ; SP 28802 ; 18870980
• MDR Report Key: 6226830
• MDR Text Key: 63981733
• Report Number: 3003184440-2016-00001
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 00850653006016
• UDI-Public: (01)00850653006016(17)180630(10)J1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2016,10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Lot Number: J1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Distributor Facility Aware Date: 10/12/2016
• Device Age: 1 HR
• Event Location: Home
• Date Report to Manufacturer: 10/13/2016
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 69