MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Swelling (2356); Test Result (2695)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Large effusions in both knees [joint effusion].Repeat effusions in knees [joint effusion].Swelling in both knees [joint swelling].High white blood cell counts [white blood cell count increased].This serious spontaneous, complaint report was received from a physician in united states.This report concerns a (b)(6) female who experienced large effusions in both knees, repeat effusions in knees, swelling in both knees, and high white blood cell counts during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, once/single, for osteoarthritis from (b)(6) 2016.It was reported that the patient received the first injection of a repeat series of euflexxa on (b)(6) 2016.The patient has received several series of euflexxa in the past and the patient was always pleased with the results.The physician reported that on (b)(6) 2016, the patient received her first of a repeat series of euflexxa.The physician injected both knees.Following receipt of injections, the patient reported severe swelling and large effusions in both knees.On (b)(6) 2016, the physician ran blood work and drained both knees and sent samples to pathology for testing.The physician reported that the blood work revealed high white blood cell counts and cultures were negative.On (b)(6) 2016, the patient returned with repeat effusions, her knees were again drained, and samples were sent to pathology.The physician reported that the patient was treated with corticosteroid injections and has been wheel chair bound.Action taken with euflexxa was dose withdrawn.On an unknown date, the outcome of large effusions in both knees was recovered, the outcome of swelling in both knees was not recovered, the outcome of repeat effusions in knees was not recovered.The patient`s procedure was significant for drained both knees and knees drained (from (b)(6) 2016).The following concomitant medication was reported: celebrex, naprosyn, prempro.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.(b)(4).

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Knee effluent came back positive for strep [arthritis bacterial].Large effusions in both knees [joint effusion].Repeat effusions in knees [joint effusion].Swelling in both knees [joint swelling].Pain in both knees[arthralgia].High white blood cell counts [white blood cell count increased].This serious spontaneous, complaint report was received from a physician in united states.This report concerns a (b)(6) female who experienced knee effluent came back positive for strep orelis in both knees, large effusions in both knees, repeat effusions in knees, swelling in both knees, pain in both knees, and high white blood cell counts during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, once/single, for osteoarthritis from (b)(6) 2016.The physician reported that the patient has bilateral advanced oa in her knees and they are trying to forego surgery.It was reported that the patient received the first injection of a repeat series of euflexxa on (b)(6) 2016.The patient has received several series of euflexxa in the past and the patient was always pleased with the results.The physician reported that on (b)(6) 2016, the patient received her first of a repeat series of euflexxa.The physician injected both knees.24 hours after receiving the injections, the patient reported severe swelling, pain, and large effusions in both knees.On (b)(6) 2016, the physician ran blood work and drained both knees and sent samples to pathology for testing.Aspiration of 30-40ml was done on both knees and the fluid removed looked like it might be infected being greenish in color and opaque.The physician reported that the blood work revealed high white blood cell counts and cultures were negative.On (b)(6) 2016, the patient returned with repeat effusions, her knees were again drained, and samples were sent to pathology.The physician reported that one grew strep.Orelis at 21 days and the other subsequently also grew strep.Orelis.As far as he remembered it was the left knee that was the worst and first grew strep.Orelis and the right followed.The patient was treated with intravenous antibiotics and temporarily had a picc line inserted.This was subsequently removed for fear of contamination.The physician reported that the patient was treated with corticosteroid injections and has been wheel chair bound.Action taken with euflexxa was dose withdrawn.On an unknown date, the outcome of large effusions in both knees was recovered, the outcome of swelling in both knees and pain in both knees was not recovered, the outcome of repeat effusions in knees was not recovered.The patient`s procedure was significant for drained both knees and knees drained (from (b)(6) 2016), and picc line placed.The following concomitant medication was reported: celebrex, naprosyn, prempro.At the time of reporting the case outcome was not recovered.Additional information received on 31 march 2016 from initial reporter: case amended to medically confirmed.Event of arthritis bacterial added.Narrative updated.Additional information received on 14 april 2016 from initial reporter: additional event of knee pain was added.Initial event of septic arthritis updated to septic arthritis streptococcal.Procedure updated.Narrative updated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Knee effluent came back positive for strep orelis in both knees [septic arthritis streptococcal].Large effusions in both knees [joint effusion].Repeat effusions in knees [joint effusion].Swelling in both knees [joint swelling].Pain in both knees [arthralgia].High white blood cell counts [white blood cell count increased].This serious spontaneous, complaint report was received from a physician in united states.This report concerns a (b)(6) year-old female who experienced knee effluent came back positive for strep orelis in both knees, large effusions in both knees, repeat effusions in knees, swelling in both knees, pain in both knees, and high white blood cell counts during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, once/single, for osteoarthritis from (b)(6) 2016.The physician reported that the patient has bilateral advanced oa in her knees and they are trying to forego surgery.It was reported that the patient received the first injection of a repeat series of euflexxa on (b)(6) 2016.The patient has received several series of euflexxa in the past and the patient was always pleased with the results.The physician reported that on (b)(6) 2016, the patient received her first of a repeat series of euflexxa.The physician injected both knees.The 24 hours after receiving the injections, the patient reported severe swelling, pain, and large effusions in both knees.On (b)(6) 2016, the physician ran blood work and drained both knees and sent samples to pathology for testing.Aspiration of 30-40ml was done on both knees and the fluid removed looked like it might be infected being greenish in color and opaque.The physician reported that the blood work revealed high white blood cell counts and cultures were negative.On (b)(6) 2016, the patient returned with repeat effusions, her knees were again drained, and samples were sent to pathology.The physician reported that one grew strep orelis at 21 days and the other subsequently also grew strep orelis.As far as he remembered it was the left knee that was the worst and first grew strep orelis and the right followed.Lab results received for synovial fluid collected on (b)(6) 2016 noted strep orelis in the left klnee only.The patient was treated with intravenous antibiotics and temporarily had a picc line inserted.This was subsequently removed for fear of contamination.The physician reported that the patient was treated with corticosteroid injections and has been wheel chair bound.Action taken with euflexxa was dose withdrawn.On an unknown date, the outcome of large effusions in both knees was recovered, the outcome of swelling in both knees and pain in both knees was not recovered, the outcome of repeat effusions in knees was not recovered.The patient`s procedure was significant for drained both knees and knees drained (from (b)(6) 2016), and picc line placed.The following concomitant medication was reported: celebrex, naprosyn, prempro.The following laboratory values were relevant: bacterial test: anaerobic culture (negative), (b)(6) 2016.Bacterial test: anaerobic culture (negative), (b)(6) 2016.Culture: streptococcus mitis/oralis (positive), (b)(6) 2016.Culture: (negative), (b)(6) 2016.Culture: (positive), (b)(6) 2016.Culture: (positive), (b)(6) 2016.Fungal test: fungal culture (negative), (b)(6) 2016.Fungal test: fungal smear (negative), (b)(6) 2016.Fungal test: fungal culture (negative), (b)(6) 2016.Fungal test: fungal smear (negative), (b)(6) 2016.Gram stain: (negative), (b)(6) 2016.Gram stain: (negative), (b)(6) 2016.Mycobacterium test: acid fast bacilli culture (negative), (b)(6) 2016.Mycobacterium test: mycobacteria culture (negative), (b)(6) 2016.Mycobacterium test: acid fast bacilli culture (negative), (b)(6) 2016.Mycobacterium test: mycobacteria culture (negative), (b)(6) 2016.Pathology test: (no assessment), (b)(6) 2016.Pathology test: (unknown), (b)(6) 2016.Synovial fluid analysis: cloudy, (b)(6) 2016.Synovial fluid analysis: turbid, (b)(6) 2016.Synovial fluid analysis: yellow, (b)(6) 2016.Synovial fluid analysis: orange, (b)(6) 2016.White blood cell count: (elevated), (b)(6) 2016.At the time of reporting the case outcome was not recovered.Additional information received on 31 march 2016 from initial reporter: case amended to medically confirmed.Event of arthritis bacterial added.Narrative updated.Additional information received on 14 april 2016 from initial reporter: additional event of knee pain was added.Initial event of septic arthritis updated to septic arthritis streptococcal.Procedure updated.Narrative updated.Additional information received on 26 april 2016 from initial reporter: laboratory data of both left and right knee synovial fluid.Narrative updated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case number, others = (b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 5531324
• MDR Text Key: 41338041
• Report Number: 3000164186-2016-00006
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2017
• Device Catalogue Number: 6301182010
• Device Lot Number: L13314A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/16/2016
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: NAPROSYN (NAPROXEN)
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Weight: 64