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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Erythema (1840); Pain (1994); Dizziness (2194); Arthralgia (2355); Ambulation Difficulties (2544); Balance Problems (4401)

Event Date 05/01/2021

Event Type  Injury  

Event Description

Harder to walk on his right knee and it has since gotten worse [gait disturbance].Knee was going to give out [joint instability].Toothache like pain in his right knee/ right knee was sore to the touch/ he puts weight on his right knee, he has horrific pain [arthralgia].Redness [erythema].Stomach ache [abdominal pain upper].Light headed [dizziness].Case narrative: this is a serious complaint, spontaneous case received from a consumer in united states.This report concerns a 55-year-old male who experienced harder to walk on his right knee and it has since gotten worse, knee was going to give out, toothache like pain in his right knee/ right knee was sore to the touch/ he puts weight on his right knee, he has horrific pain, redness, stomach ache and light headed during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown concentration, dose, and route, given weekly for three weeks, for an unknown indication from 24-apr-2021 to 08-may-2021.The patient reported getting three injections of euflexxa in both knees.First dose was on (b)(6) 2021, second on (b)(6) 2021, and third on (b)(6) 2021.After third injection patient experienced redness, and "toothache like" pain in his right knee.He stated that he had stem cell and platelet rich plasma (prp) a couple years ago and things got better for a while.He also reported that he got synvisc in his left knee a while back and it worked well and he wanted to get this in his right knee, but his insurance wouldn't pay.The patient stated prior to euflexxa he had a steroid shot, but that didn't work.After the euflexxa injections it was harder to walk on his right knee and it had gotten worse since.On sunday ((b)(6) 2021) at 9 am, the pain was so severe he felt lightheaded and had a stomachache.When he put weight on his right knee, he had "horrific pain".Yesterday ((b)(6) 2021) he felt like his knee was going to give out, so bought a cane to give support and has applied for short term disability.He said that euflexxa was less painful than other shots, during administration, but afterwards, his right knee was sore to the touch for a whole week after the shot.He stated he was almost pain-free with his left knee after injections, but since then he was experiencing mild pain.No additional information provided.The patient experienced significant disability due walking difficulty action taken with euflexxa was not applicable.At the time of this report, the outcomes of harder to walk on his right knee and it has since gotten worse, knee was going to give out, toothache like pain in his right knee/ right knee was sore to the touch/ he puts weight on his right knee, he has horrific pain, redness, stomach ache and light headed were not recovered.The patient's med hist/procedure was significant for platelet rich plasma (prp) (from unknown start date to unknown stop date) and a-fib (from unknown start date to unknown stop date) and cane user (from unknown start date to unknown stop date) and stem cell (from unknown start date to unknown stop date).The patient's past drug therapy was significant for synvisc (from unknown start date to unknown stop date) and steroid shot (from unknown start date to unknown stop date).The following concomitant medications were reported: metformin (from an unknown start date to an unknown stop date), lisinopril (from an unknown start date to an unknown stop date), verapamil (from an unknown start date to an unknown stop date), metoprolol (from an unknown start date to an unknown stop date).The event harder to walk on his right knee and it has since gotten worse was reported as serious.The events knee was going to give out, toothache like pain in his right knee/ right knee was sore to the touch/ he puts weight on his right knee, he has horrific pain, redness, stomach ache and light headed were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related, company causality: related, other case numbers: (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.Qr investigation: (b)(6) 2021: the nature of the complaint is such that it does not meet the criteria for a medication device reportable event.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.Root cause was not detected.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.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
• MDR Report Key: 16439034
• MDR Text Key: 310231615
• Report Number: 0002244564-2021-00025
• 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: 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

• 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: 02/24/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: LISINOPRIL (LISINOPRIL),; METFORMIN (METFORMIN),; METOPROLOL (METOPROLOL),; VERAPAMIL (VERAPAMIL),
• Patient Outcome(s): Disability
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 150 KG