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

Lot Number J-2

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

Orthogenrx evaluated manufacturing activities, related to hyaluronate prefilled syringe products (including genvisc 850), from the last two years (2015 and 2016) to demonstrate the microbial quality at all stages of the process.All the data demonstrated that product sterility assurance is in compliance (reference report (b)(4) 5jan2017).Additionally, orthogenrx conducted an evaluation of the lethality index (f0) [which measures process sterilization effectiveness (the in-process specification is f0=8)], for 2015 and 2016 validation batches.The f0 specification is always achieved and was in the range of 9.7 to 14 for the 2015 and 2016 validations, respectively.Genvisc 850 routine production lots# j-1, j-2, and k-1 manufactured in 06/19/2015, 07/01/2015, and 01/18/2016, respectively, were also evaluated.All routine manufacturing is also within the same f0 range, demonstrating process sterilization effectiveness (reference report ogx-(b)(4) 5jan2017).The product sterility assurance is also certified with in-process controls (chemical and biological indicators of sterilization) and final bacteria endotoxins and sterility test results for product release, among other release quality specifications.All the products manufactured in 2015 and 2016, in particular lot j-2, manufactured in 07/01/2015, complied with product sterility assurance and pass all the product release specifications.Presently, we are conducting sterility studies from non-compromise lot j-2 supplies (sent to laboratory testing directly from orthogenrx warehouse).Results will be available on 31jan2017.We will also test the remaining samples from vitality medical center.Results are expected by 3feb2017.Based on the data evaluated as of 5jan2017 (on all the products manufactured in 2015 and 2016) and the fact that all the components and manufacturing in-process controls complied with the endotoxins and the sterility testing and that products passed all the product release specification requirements, orthogenrx concludes that genvisc 850 lot j-2, manufactured in 07/01/2015, conforms with the sterility assurance program.

Event Description

Health care provider (hcp) reported to ae assessor that the pt.Received the 5th left knee injection of genvisc 850 on (b)(6) 2016.The hcp was contacted by the hospital the pt.Was in the hospital currently; no date of admission was available.The hcp indicated the pt.Experienced the adverse event of left knee pain, swelling and reduced range of motion on (b)(6) 2016.During the hospitalization, the pt.Was sent to the operating room (or) to "wash the knee out" and culture the joint.The culture indicated the presence of (b)(6) in the joint.The blood was also cultured with the presence of (b)(6).The treatment included antibiotics.Possible sources of (b)(6) during the knee injection procedure are the open community bottles of omnipaque and/or lidocaine used in the procedure.Another possible source was the room during the knee injection procedure if an aseptic technique was not followed.The (b)(6) cultured in the pts.Joint and blood are likely a contributing factors to the reported left knee pain, reduced range of motion and swelling.Genvisc 850 left knee injection cannot be excluded as a contributing factor to the left knee pain, swelling and reduced range of motion.This case will be closed as serious due to the report of the left knee swelling with hospitalization including treatment with the or procedure to "wash the knee out" due to the (b)(6) and the required antibiotics.This case will be closed without further follow-up from the ae assessor.(b)(6) conducted an investigation for possible clinic contamination.(b)(6)concluded that the single use omnipaque vials were the source of the contamination.(b)(6) recommended remediation guidelines to the clinic.This case will be closed without further follow-up from ae assessor.If additional information becomes available, the case will be reopened for further investigation.

Manufacturer Narrative

The initial submission was erroneously submitted as a 5 day report and life threatening.This was a clerical error.This report is amended to a 30 day report.Based upon the information provided, orthogenrx was not required to initiate action to prevent an unreasonable risk of substantial harm.

Event Description

Corrections made.

• 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: 6275002
• MDR Text Key: 65667705
• Report Number: 3003184440-2017-00011
• Device Sequence Number: 1
• Product Code: MOZ
• 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,Followup
• Report Date: 01/24/2017,12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Lot Number: J-2
• 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: 01/24/2017
• Distributor Facility Aware Date: 12/23/2016
• Event Location: Other
• Date Report to Manufacturer: 12/23/2016
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR