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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.
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Brand NameGENVISC 850
Manufacturer (Section D)
ctra. m-300, km 30, 500
alcala de henares (madrid), 28802
SP 28802
Manufacturer (Section G)
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
MDR Report Key6275002
MDR Text Key65667705
Report Number3003184440-2017-00011
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
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
Date FDA Received01/24/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Lot NumberJ-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 FDA01/24/2017
Distributor Facility Aware Date12/23/2016
Event Location Other
Date Report to Manufacturer12/23/2016
Date Manufacturer Received12/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2015
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: 01/24/2017 Patient Sequence Number: 1