MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Chest Pain (1776); Headache (1880); Pain (1994); Dizziness (2194); Ambulation Difficulties (2544)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 26-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency was unable to walk unless she rubs her knees twice a day, had lightheadedness/dizziness, was feeling sick to her stomach, headache, stomach pain/ pain is on the right side and not on the left side and pain in her right knee/had nonstop pain.Also device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.The patient had past treatment with steroid injection in right knee.The patient had a past medical history of being a "heart patient" and had occasional chest pain (that was "seemingly more" since this synvisc one injection; pain is on the right side and not on the left side).On an unknown date in (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose: unknown) for osteoarthritis knee (batch/lot number: 7rsl021, expiry date: unknown).The patient did not know if she received an anesthetic at the time of the injection.The patient did not engage in any activities after her injection.On an unknown date in 2017, after unknown latency, the patient had nonstop pain and she was unable to walk unless she rubbed her knees twice a day.She states that she was informed by doctor by a letter and a phone call 5 days ago that she had received the recalled lot of synvisc-one "at least 7-8 weeks ago".It was reported that 2 weeks after the injection the patient went to the office to complain of these symptoms and she was prescribed a strong pain medication and nothing had helped.She states she was also treating it with paracetamol (tylenol).On an unknown date in 2017, after unknown latency, the patient complained of light headedness, dizziness, feeling sick to her stomach, headache, and stomach pain.Corrective treatment: strong pain medication, paracetamol (tylenol) for pain in her right knee/had nonstop pain; not reported for rest of the events.Outcome: not recovered for all the events.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented." seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 03-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and experienced light headedness, stomach upset, headache, stomach pain, pain in her right knee/had nonstop pain and was unable to walk.The events are temporally related to device.Moreover, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

Event Description

This unsolicited case from united states was received on 26-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency was unable to walk unless she rubs her knees twice a day/unable to walk, had lightheadedness/ dizziness, was feeling sick to her stomach, headache, stomach pain/pain is on the right side and not on the left side and pain in her right knee/had nonstop pain.Also device malfunction was identified for the reported lot number.No concurrent condition was provided.The patient had past treatment with steroid injection in right knee.The patient had a past medical history of being a "heart patient", had pacemaker placed, had heart surgery, coronary artery disease, neck surgery on right side and stent on left side, and had occasional chest pain (that was "seemingly more" since this synvisc one injection; pain was on the right side and not on the left side).Concomitant medication included ciclosporin (restasis) for eye surgery, tramadol hydrochloride (tramadol) for pain, gabapentin for moderate pain, lovastatin, atenolol for blood pressure, paracetamol (tylenol arthritis) for pain, acetylsalicylic acid (aspirin).On an unknown date in (b)(6) 2017 (in the night), the patient initiated treatment with intra-articular synvisc one injection once (dose: unknown) for osteoarthritis knee (batch/lot number: 7rsl021, expiry date: unknown).The patient did not know if she received an anesthetic at the time of the injection.The patient did not engage in any activities after her injection.On an unknown date in 2017, after unknown latency, the patient had nonstop pain and she was unable to walk unless she rubbed her knees twice a day.She states that she was informed by doctor by a letter and a phone call 5 days ago that she had received the recalled lot of synvisc one "at least 7-8 weeks ago".It was reported that 2 weeks after the injection the patient went to the office to complain of these symptoms and she was prescribed a strong pain medication and nothing had helped.She states she was also treating it with paracetamol (tylenol).On an unknown date in 2017, after unknown latency, the patient complained of light headedness, dizziness, feeling sick to her stomach, headache and stomach pain.On (b)(6) 2017, the patient experienced excruciating pain in the right knee, was unable to walk unless patient used unspecified pain cream.Corrective treatment: strong pain medication, paracetamol (tylenol) for pain in her right knee/had nonstop.Pain; not reported for rest of the events.Outcome: not recovered for all the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number 51607 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction follow up information was received on 15-jan-2018.Global ptc number was added.Text was amended accordingly.Additional information was received on 13-feb-2017 from the patient.Medical history and concomitant drug were added.Verbatim of unable to walk unless she rubs her knees twice a day/unable to walk and stomach pain/pain was on the right side and not on the left side was updated.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 13-feb-2018:the follow up information does not change the previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and experienced light headedness, stomach upset, headache, stomach pain, pain in her right knee/had nonstop pain and was unable to walk.The events are temporally related to device.Moreover, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7208761
• MDR Text Key: 98293308
• Report Number: 2246315-2018-00041
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Patient Sequence Number: 1
• Treatment: ASPIRIN(CON.); ATENOLOL(CON.); GABAPENTIN(CON.)START; LOVASTATIN(CON.); RESTASIS(CON.)START; TRAMADOL(CON.)START; TYLENOL ARTHRITIS(CON.)
• Patient Outcome(s): Other
• Patient Age: 76 YR