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

Catalog Number 6301182010

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Arthritis (1723); Pain (1994); Arthralgia (2355); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Not able to move for about four weeks [immobile].Contractions and muscle jumping in the hamstring and the back of the treated knee [muscle contractions involuntary].There was some cartilage in there and i think the medication went in and ripped it up [also described as there was damage done] [cartilage injury].Pain [clarified by contractions and muscle jumping in the hamstring and the back of the treated knee] [arthralgia].Knee swelling [joint swelling].Osteoarthritis did not improve following the euflexxa series [device ineffective].This serious complaint, spontaneous report was received from a consumer in united states.Case initially reported as non-serious but upgraded to serious on 18-jan-2017.This report concerns a (b)(6) female who experienced not able to move for four weeks, contractions and muscle jumping in the hamstring and the back of the treated knee, there was some cartilage in there and i think the medication went in and ripped it up, pain, knee swelling, and osteoarthritis did not improve following the euflexxa series during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, weekly, for osteoarthritis from (b)(6) 2016.The patient reported that she was administered euflexxa for osteoarthritis of the right knee.The patient reported that she received her first euflexxa injection on (b)(6) 2016.She reported being on the couch all day and having an awful reaction to the product.It was clarified that the reaction was pain and described the pain as contractions and muscle jumping in the hamstring and the back of the treated knee.A second dose was administered on (b)(6) 2016, with a similar but less severe reaction.The patient received her third dose on (b)(6) 2016.The patient's osteoarthritis did not improve following the euflexxa series, and on (b)(6) 2016, under the care of a different physician, the patient underwent knee surgery.The patient feels that treatment with euflexxa hastened the need for knee surgery.Upon follow up the patient further reported that after the euflexxa injection she was not able to move for four weeks.She reported she had pain before receiving the injections, but was at least able to hobble around, as opposed to after the medication.The patient clarified that the knee surgery was a total knee replacement.She claimed to have swelling in the knee that was present after euflexxa and before her surgery.The patient also stated there was some cartilage in there (presumed to be discussing the knee) and she believes the medication went in and ripped it up.Action taken with euflexxa was dose not changed.On an unknown date, the outcome of not able to move for about four weeks was recovered.The outcome of pain was unknown.The outcome of "there was some cartilage in there" and "i think the medication went in and ripped it up [also described as there was damage done]" was not recovered.The outcome of "knee swelling" was not recovered, the outcome of "contractions and muscle jumping in the hamstring and the back of the treated knee " was not recovered, the outcome of "osteoarthritis did not improve following the euflexxa series" was unknown.The patient`s medical history was significant for thyroid condition and glaucoma.The patient`s past drug therapy was significant for corticosteroid injections.The patient`s procedure was significant for complete knee replacement.Concomitant medication use was reported as unknown thyroid medication.At the time of reporting the case outcome was not recovered.Additional information was received on 18-jan-2017 from the initial reporter: case upgraded to serious.Additional events, outcomes, and seriousness criteria updated.Narrative updated.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: (b)(4).This ae occurred in the us 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 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.(b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 6310686
• MDR Text Key: 66817678
• Report Number: 3000164186-2016-00040
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2016

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
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 66