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Lot Number J-2
Device Problem No Apparent Adverse Event (3189)
Patient Problems Pain (1994); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373)
Event Date 12/16/2016
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)). 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)). 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 (b)(6) 2017. We will also test the remaining samples from vitality medical center. Results are expected by (b)(6) 2017. 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 provided (hcp) reported to ae assessor that the pt. Presented to the clinic with pain, swelling, stiffness and restricted range of motion in the left knee on (b)(6) 2016 after the first injection of genvisc 850 was given on (b)(6) 2016 in the left knee. Pt. Has a medical history of high school injury to left knee with severe osteoarthritis on the medial aspect and moderate to severe on the lateral aspect. His history includes meniscus surgery. Pt. Performs a heavy lifting job in a warehouse and wears a soft knee brace. Pt. Presented on (b)(6) 2016 for the first injection of genvisc 850 of the left knee. Pt. Rated pain was 7 out of 10. On (b)(6) 2016, pt. Presented to the clinic with left knee pain,swelling,stiffness and restricted range of motion. The pt. Was prescribed an ace bandage, ice therapy with rest, pain medication- tramadol, and a solumedrol dose pack. This case will be closed as serious due to the adverse events reported include left knee injection site joint swelling, joint stiffness, pain and reduced range of motion. The causal role of the genvisc 850 cannot be excluded as contributing to the knee pain, swelling, stiffness and restricted range of motion in the event; however pt. Underlying disease progression cannot be excluded. Pt. Had a pending knee replacement scheduled however the (b)(6) was investigating the reporter clinic for possible contamination at the patient knee injection site. As a result of the concern for possible knee contamination, the hcp encouraged the pt. To go to the emergency room for an evaluation. At the hospital, the patient's knee was surgically washed out. The patient's joint and blood cultures were reported verbally as negative for microorganisms. This case will be closed without follow-up from the ae assessor and is limited in investigation by the information available to the ae assessor.
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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 28802
MDR Report Key6265649
MDR Text Key65345301
Report Number3003184440-2017-00010
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
Report Date 01/19/2017,12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 FDA01/19/2017
Distributor Facility Aware Date12/20/2016
Event Location Other
Date Report to Manufacturer12/20/2016
Date Manufacturer Received12/20/2016
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: 01/19/2017 Patient Sequence Number: 1