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); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Car accident [road traffic accident].Hip replacement [hip arthroplasty].Unable to continue working as a nurse [loss of personal independence in daily activities].Bone on bone, arthritis [arthritis].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer who is also a nurse in united states.This report concerns a female of an unknown age who had car accident, hip replacement, unable to continue working as a nurse, bone on bone and arthritis during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for an unknown indication from an unknown start date which was more than seven years ago to an unknown stop date.The patient who was also a nurse, reported that she was taking euflexxa for more than seven years ago and stated it worked for her.The patient reported she had a car accident on 20-nov-2020 and had to undergo a hip replacement (date unknown), but her hip replacement was due to her arthritis which occurred while she was on euflexxa.The patient also stated that her right knee was now "bone on bone" and would also need the other hip replaced.The patient also stated she was unable to continue working as a nurse.The patient stated she was happy with euflexxa.Action taken with euflexxa was unknown.At the time of this report, the outcome of hip replacement was unknown, the outcome of unable to continue working as a nurse was not recovered, the outcome of bone on bone, arthritis was not recovered.On 20-nov-2020, the outcome of car accident was recovered.No concomitant medication was reported.The events car accident, hip replacement were reported as serious.The events unable to continue working as a nurse, bone on bone, arthritis were reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related company causality: not related for events of 'car accident', 'hip replacement' and 'unable to continue working as a nurse'.Other case numbers: internal # - others = (b)(4).Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the 'car accident', 'hip replacement' and 'unable to continue working as a nurse' events as there is no clinical evidence.The fact that patient is now 'unable to continue working as a nurse' might most likely be related to the car accident and hip replacement (caused to the accident) and not to euflexxa which it was proved to work in this patient as also reported.Furthermore, limited information regarding dosing regimen, indication, stop date etc.Making difficult to establish causal temporal relationship.This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive/ 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.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 16214442
• MDR Text Key: 307817420
• Report Number: 3000164186-2021-00024
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female