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

Catalog Number 6301182010

Device Problems Unexpected Therapeutic Results (1631); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Arthritis (1723); Deformity/ Disfigurement (2360)

Event Type  Injury  

Event Description

Knee out of alignment and requiring surgery [knee deformity].Consumer reported the injections did not do anything [device ineffective].Case narrative: this is a serious spontaneous complaint case received from a consumer in the united states.This report concerns a 59-year-old female who reported the injections did not do anything during treatment and the knee was out of alignment and required surgery with euflexxa (sodium hyaluronate) solution for injection, 1 injection weekly for three weeks, for osteoarthritis from (b)(6) 2022 to (b)(6) 2022.On (b)(6) 2022, the patient reported she received euflexxa injections in the right knee on (b)(6) 2022, (b)(6) 2022 and (b)(6) 2022 and stated that the injections did not do anything.After the injections, the patient had a magnetic resonance imaging (mri) which showed there was more arthritis in the knee.The patient was referred to another specialist who stated the alignment was off in the knee and referred the patient to a surgeon who was setting up surgery for her right knee.The patient was requesting a refund since the euflexxa injections did not work for her.No further information, consumer did not have the lot numbers and expiration dates.The consumer reported the injections did not do anything was medically significant.Action taken with euflexxa was not applicable.The patient's med hist/procedure was significant for osteoarthritis (from unknown start date to unknown stop date) and partial knee replacement of left knee (from unknown start date to unknown stop date).No concomitant medication was reported.The event of knee being out of alignment and requiring surgery was reported as serious.The event of euflexxa injections did not work was non-serious.At the time of reporting the case outcome was unknown.Sender comment: the association between euflexxa and the knee deformity requiring surgery is not related due to the absence of a plausible time relationship to drug/device use since the patient's osteoarthritis was described to be underlying and a confounding medical history of a partial knee replacement of left knee could better provide an explanation to the event.Furthermore, the device ineffectivity is interpreted in the context of the labeled indication for product which is to relieve knee pain due to osteoarthritis which does not refer to any claims concerning the anatomical and structural integrity of the knee joint.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not 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.

Event Description

Knee out of alignment and requiring surgery [knee deformity].Consumer reported the injections did not do anything [device ineffective].Case narrative: this is a serious spontaneous complaint case received from a consumer in the united states.This report concerns a 59-year-old female who reported the injections did not do anything during treatment and the knee was out of alignment and required surgery with euflexxa (sodium hyaluronate) solution for injection, 1 injection weekly for three weeks, for osteoarthritis from (b)(6) 2022.On (b)(6) 2022, the patient reported she received euflexxa injections in the right knee on (b)(6) 2022 and stated that the injections did not do anything.After the injections, the patient had a magnetic resonance imaging (mri) which showed there was more arthritis in the knee.The patient was referred to another specialist who stated the alignment was off in the knee and referred the patient to a surgeon who was setting up surgery for her right knee.The patient was requesting a refund since the euflexxa injections did not work for her.No further information, consumer did not have the lot numbers and expiration dates.The consumer reported the injections did not do anything was medically significant.Action taken with euflexxa was not applicable.The patient's med hist/procedure was significant for osteoarthritis (from unknown start date to unknown stop date) and partial knee replacement of left knee (from unknown start date to unknown stop date).No concomitant medication was reported.The event of knee being out of alignment and requiring surgery was reported as serious.The event of euflexxa injections did not work was non-serious.At the time of reporting the case outcome was unknown.Sender comment: the association between euflexxa and the knee deformity requiring surgery is not related due to the absence of a plausible time relationship to drug/device use since the patient's osteoarthritis was described to be underlying and a confounding medical history of a partial knee replacement of left knee could better provide an explanation to the event.Furthermore, the device ineffectivity is interpreted in the context of the labeled indication for product which is to relieve knee pain due to osteoarthritis which does not refer to any claims concerning the anatomical and structural integrity of the knee joint.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = (b)(4).Internal # - affiliate = (b)(4).Internal # - complaint = (b)(4).E2b company number = (b)(4).Mw 3500a mfr.Rpt.# = 3000164186-2022-00029.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.Qa investigations 25-jul-2022: according to document (b)(4), rational for investigation of lack of effect complaints for euflexxa.Euflexxa is indicated for pain relief in patients with osteoarthritis and therefore does not help everyone in the same manner.Btg performs a routine trend analysis of all complaint types.If an adverse trend is established, the need for capa will be reevaluated.The review of supporting data did not reveal any quality issue.Based on the investigation detailed above, 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.Root cause cannot be detected.Classification: minor.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.

Manufacturer Narrative

0.

• 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
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 15083132
• MDR Text Key: 296374888
• Report Number: 3000164186-2022-00029
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• 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
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female