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Model Number 50653-0006-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 03/31/2022
Event Type  Injury  
Event Description
The genvisc 850 call center was notified by an orthogenrx employee that an hcp reported a male patient was admitted to a hospital and diagnosed with a right knee intra-articular joint infection. The ae assessor spoke with the hcp (who gave the injection) for the investigation of the complaint of the right knee intra-articular joint infection on (b)(6) 2022 after a third right knee intra-articular genvisc 850 injection on (b)(6) 2022 the patient's medical history includes osteoarthritis, diabetes, gout, copd, chronic low back pain, coronary artery disease, atrial fibrillation, bladder cancer with previous injections of genvisc 850 with no complaints. The patient received right knee intra-articular genvisc 850 injections with the first on (b)(6) 2022 , second on (b)(6) 2022 and third on (b)(6) 2022. The hcp's medical assistant did the preparation which included preparing the patient's knee and the syringes that held the lidocaine, omnipaque and genvisc850. The hcp could not provide details of how the ma prepared. The hcp provided the injections. The patient received the left knee intra-articular genvisc 850 injections with the first on (b)(6) 2022 , second on (b)(6) 2022 and third on (b)(6) 2022. When the patient received the third left knee intra-articular genvisc 850 injection on (b)(6) 2022, the patient did not complain about the right knee. On (b)(6) 2022 the patient was admitted to the hospital and diagnosed with a right knee intra-articular joint infection. The patient at the hospital was taken to the or for a knee wash out procedure and is currently on iv antibiotics and recovering. The culture grew out staph and serratia. Staph is a bacteria found on human skin, nose, under arm, groin etc. Serratia is a bacteria found on water surfaces such as "toilet bowl, shower stall, bathtub and pet's water dish as a pink film" as well as "dust in the feces of animals and humans". It is also found in the soil. The hcp said it is unknown what the patient did after leaving the clinic, whether he gardens, and whether the patient has any pets. No cultures were done at the clinic. The causal role of the genvisc 850 and/or the administration procedure for the right knee infection, a serious case, cannot be excluded due to the temporal sequence of the events. Meiji pharma (b)(4) comment: based on the temporal sequence, the causal role of sodium hyaluronate in the event developed cannot be ruled out as well as the omnipaque and lidocaine and/or the administration procedure in the right knee. The vials used in the administration procedure (genvisc850, omnipaque and lidocaine) are not available, therefore an accurate assessment of the causal role of each co-suspect md/drug will be not possible. 4/15/22 the hcp mentioned that they have had no other complaints (no other adverse events with genvisc 850 which includes the more than 100 injections given with the same lot number this patient received on (b)(6) 2022). This patient had 5 injections of genvisc 850 without complaints. Serratia is a very unusual bacteria to find in a healthcare setting. This patient who has diabetes is more at risk for infection in daily life. It is unlikely the genvisc 850 product or the administration procedure contributed to the bacterial infection. The investigation from genvisc lot r-12 (production lot # 28/21) bacterial & fungal testing: all results are ok and lot 28/21 passes the test as sterile.
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Brand NameGENVISC 850
Manufacturer (Section D)
avda. de madrid 94
28802 alacala de henares
MDR Report Key14597390
MDR Text Key293378871
Report Number3011402886-2022-00001
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier00850653006016
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/11/2022,04/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50653-0006-01
Device Lot NumberR-12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/09/2022
Device Age6 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/03/2022 Patient Sequence Number: 1