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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544); Balance Problems (4401)

Event Type  Injury  

Event Description

Hip surgery.In a lot of pain.His knee hurts [arthralgia].Knee pain causes him to limp when he tries to walk more than 3/4 of a mile [gait disturbance], case narrative: case (b)(4) is a serious spontaneous case received from a non-health professional via a regulatory authority in united states.This report concerns a male of unknown age who had hip surgery, in a lot of pain, his knee hurts and knee pain causes him to limp when he tries to walk more than 3/4 of a mile during treatment with euflexxa (sodium hyaluronate) solution for injection intra-articular, unknown concentration, dose and indication, from an unknown start date to an unknown stop date.The patient reported that he was in the hospital to have hip surgery on (b)(6) 2021 and that he was in a lot of pain, particularly his knee hurt, causing him to limp if he tried to walk more than three-quarters of a mile, even though he needed to gain strength and recover in his hips.The patient was hospitalized (b)(6) 2021 due to hip surgery.Action taken with euflexxa was unknown.At the time of reporting, the outcome of hip surgery, in a lot of pain, his knee hurts and knee pain causes him to limp when he tries to walk more than 3/4 of a mile was unknown.No concomitant medication was reported.The event hip surgery was reported as serious.The events in a lot of pain, his knee hurts and knee pain causes him to limp when he tries to walk more than 3/4 of a mile 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: related: athralgia, gait disturbance.Not related: hip surgery, pain.Ferring sender comment: the reason for the hip surgery is unknown, however, based on the known safety profile of sodium hyaluronate the surgery is considered not related to sodium hyaluronate.The pain is more likely considered related to the surgery and not related to sodium hyaluronate.Other case numbers: internal #: mw5102526.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 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
• MDR Report Key: 16439036
• MDR Text Key: 310428322
• Report Number: 0002244564-2021-00032
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male