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

Catalog Number 6301182010

Device Problem Lack of Effect (4065)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Needed knee replacement [knee arthroplasty].Had euflexxa shots on a knee that eventually needed a knee replacement and "it didn¿t help".[device ineffective].Case narrative: (b)(4) is a serious, spontaneous complaint received from a consumer in the united states.This report concerns a female patient who had euflexxa shots on a knee that eventually needed a knee replacement and it didn't help during treatment with euflexxa (sodium hyaluronate) solution for injection 1%, unknown route and dosage, for an unknown indication from an unknown start date to an unknown stop date.Lot # not reported.The patient reported that she had euflexxa shots on a knee that eventually needed a knee replacement and it didn't help.The patient wanted to know if it would work on her other knee that will eventually need a replacement.Action taken with euflexxa was unknown.At the time of this report, the outcome of knee replacement was unknown, the outcome of had euflexxa shots on a knee that eventually needed a knee replacement and it didn't help was unknown.Concomitant medication and medical history were not reported.The event needed knee replacement was reported as serious.The event had euflexxa shots on a knee that eventually needed a knee replacement and it didn't help was reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: knee replacement is not considered to be related due to limited relevant information available, such as the patient's medical history.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - affiliate = (b)(4).Internal # - others= (b)(4).Internal # - complaint = (b)(4).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.Case correction 10-jun-2022: updated coding from drug ineffective to device ineffective.No other changes made.28-jun-2022 complaint management report: euflexxa is indicated for pain relief in patients with osteoarthritis and therefore does not help everyone in the same manner.The review of supporting data did not reveal any quality issue.Based on the investigation, this complaint is considered not confirmed and no further action will be taken at this time.Ferring will continue to monitor for this type of complaint.The investigation into this qr is now complete and considered closed.The nature of the complaint is such that it does not meet the criteria for a medical device reportable event.

• 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
• MDR Report Key: 16485969
• MDR Text Key: 310730578
• Report Number: 0002244564-2022-00025
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2023

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
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female