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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Pain (1994); Ambulation Difficulties (2544); Balance Problems (4401); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Date 05/18/2020

Event Type  Injury  

Event Description

Could not put my weight on it or walk on it [weight bearing difficulty].Could not put my weight on it or walk on [gait inability].Severe back pain and spasms [muscle spasms].Migraine [migraine].Extreme pain [pain].Knee was swollen to the size of a cantaloupe [joint swelling].Severe back pain and spasms [back pain].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer via the fda in united states.This report concerns a patient (no patient identifiers reported) who could not put weight on knee or walk on it, migraine, extreme pain, knee was swollen to the size of a cantaloupe and severe back pain and spasms during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration unk, for osteoarthritis from (b)(6) 2020 to an unknown stop date and co-suspect drug cortisone (cortisone) unknown formulation, route, concentration and dose, for unknown indication from (b)(6) 2020 to an unknown stop date.The patient reported that they received two injections of euflexxa over a two-week period injection into the left knee to treat osteoarthritis.The patient was in mild pain before the injection and was able to walk and stand for the majority of the time.The patient received the first injection on an unspecified date in (b)(6) 2020 along with a cortisone injection and seemed to tolerate it well.The second injection was administered and within 48 hours on (b)(6) 2020, the patient's knee was swollen to the size of a cantaloupe and could not put weight on it or walk on it.The patient experienced a migraine and severe back pain and spasms and thought that they were suffering from systemic inflammation.The patient was seen by their physician in (b)(6) 2020 and had fluid drained from the knee, went to the emergency room and was prescribed prednisone for nine days.The patient reported after 17 days, they were wearing a knee brace constantly and were still experiencing extreme pain.The patient was scheduled for a magnetic resonance imaging (mri) on an unknown date in 2020.No additional information was provided.The "could not put my weight on it or walk on it" was medically significant.Action taken with euflexxa was unknown.Action taken with cortisone was unknown.At the time of this report, the outcome of could not put my weight on knee or walk on it, severe back pain and spasms, migraine and knee was swollen to the size of a cantaloupe was unknown, the outcome of extreme pain was not recovered.Concomitant medication and medical history were not reported.The events could not put my weight on knee or walk on it, were reported as serious.The events severe back pain and spasms, migraine, extreme pain, knee was swollen to the size of a cantaloupe, severe back pain and spasms were reported as non-serious.At the time of reporting the case outcome was unknown (not recovered for extreme pain).Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: #: mw5094888.These aes occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This aes 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.Ferring's sender comment: contribution of euflexxa could not be ruled out based on temporal relationship.However, since it is assumed that the patient was using the product according to label, the events extreme pain, weight bearing difficulty and gait inability are confounded by the patient's underlying disease.The event of extreme pain itself could also provide a plausible explanation for the gait inability and weight bearing difficulty.Contribution of euflexxa to back pain, muscle spasms, joint swelling, and migraine could not be ruled out based on known safety profile of the product.

• 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: 16438982
• MDR Text Key: 310230989
• Report Number: 0002244564-2020-00010
• 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: 02/23/2023

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): Required Intervention; Other