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 Arthritis (1723); Bacterial Infection (1735)

Event Type  Injury  

Event Description

Septic arthritis of the knee [arthritis bacterial].Case (b)(4) is a serious spontaneous case from a medical journal by a physician in united states.This case concerns a (b)(6)-year-old male who experienced septic arthritis of the knee on an unknown date during treatment with intra-articular sodium hyaluronate (sodium hyaluronate) solution for injection for osteoarthritis.The concentration of the product, dosing regimen, treatment period and batch no.Was unknown.The septic arthritis of the knee was medically significant.The patient had a medical history significant for ankylosing spondylitis, (b)(6), non-ischemic cardiomyopathy, chronic left bundle branch block, depression, hypogonadism, as well as multifocal (b)(6) joint infections (left elbow, left wrist, right shoulder, and lumbar spine) resulting in multiple hospitalizations for sepsis.He also had a history of left acl reconstruction.He was experiencing significant pain from end-stage left knee arthritis.The patient was recommended continued conservative management.The patient later had an intra-articular injection with sodium hyaluronate by his primary care physician which was complicated by septic arthritis of the knee.Action taken to sodium hyaluronate was unknown.No concomitant medication was reported.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Sender comment (ferring): company causality is considered not related to sodium hyaluronate due to the fact that this is an immunosuppressed patient with several comorbidities and endstage knee arthritis.This ae occurred in united states and concerns the medical device sodium hyaluronate.Please report to your local health authority if required by local law.This ae is not reportable in eu because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 8443044828
• MDR Report Key: 9597604
• MDR Text Key: 189831368
• Report Number: 3000164186-2020-00002
• 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,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR