MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Fatigue (1849); Weakness (2145); Therapeutic Response, Decreased (2271); Arthralgia (2355); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(4) 2019: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee pain, fatigue, poor quality sleep.A temporal relationship can be established with the product administration.Furthermore, 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.Also the contributory role of patient's medical history cannot be underestimated either.

Event Description

Device malfunction [device malfunction].Fatigue/feeling more tired [fatigue].Not sleeping well [sleep unwell].Poor energy [energy decreased].Pain in knee [knee pain] ([pain aggravated]).Does not feel like it helped in any way [device ineffective].Case narrative: this case was cross referenced with case (b)(4) (same patient).Initial information received from united states on (b)(6) 2019 regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) years old female patient who had treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and after unknown latency experienced fatigue/feeling more tired, not sleeping well, poor energy, pain in knee and does not feel like it helped in any way.Also, device malfunction was identified for the reported lot number.The patient's past medical history included allergic rhinitis, unspecified anaemia (noted on (b)(6) 2015), eczema, unspecified mild hyperlipidaemia, caesarean section in (b)(6) 2010 and (b)(6) 2012, cholecystectomy at age of 20, functional endoscopic sinus surgery on (b)(6) 2014, tonsillectomy and generalized abdominal and right-sided pain.The patient's family history included breast cancer and migraine with mother, type 2 diabetes mellitus, hypertension and prostate cancer with father.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing gastrooesophageal reflux disease on (b)(6) 2015 with without esophagitis, penicillin allergy (noted: (b)(6) 2016) and had rash but was not sure if it was penicillin or amoxicillin that she had taken and got a rash on end of therapy, migraine (significant right sided nasal obstruction as possible etiology), vitamin d deficiency (noted on (b)(6) 2015), pain in both knees, unspecified chronicity (noted on (b)(6) 2016), non morbid obesity due to excess calories (noted on (b)(6) 2016), non-smoker, helicobacter infection, ulcer and abdominal pain upper.Concomitant medications included calcium carbonate, colecalciferol (caltrate 600+d); magnesium oxide (mag-ox); diclofenac (voltaren); meloxicam (mobic); and prednisone (deltasone).On (b)(6) 2017, the patient started using intra-articular injection of hylan g-f 20, sodium hyaluronate at a dose of 48 mg, once (lot - 7rsl021) for primary osteoarthritis of left knee.On (b)(6) 2017, it was reported that patient had pain in both knees and increased fatigue (latency: unknown).Patient was concerned about fatigue, epigastric pain and vitamin d deficiency.The patient stated that she had been feeling more tired recently and was not sleeping well (latency: unknown).The patient was also drained.She had poor energy (latency: unknown).She denied weight gain/weight loss or heat/cold intolerance.The patient noted the epigastric pain but denied nausea or vomiting, diarrhea or constipation, melena or hematochezia.She was concerned about an ulcer and h.Pylori infection.She denied chest pain, shortness of breath or palpitations.On (b)(6) 2018, patient came in the office for follow-up of recent h pylori infection and concerns about her arthritis in her knees.The pain was increased since the contaminated hylan g-f 20, sodium hyaluronate shots.Doctor recommended ortho visit.The patient had finished the antibiotics and proton pump inhibitor and her epigastric pain was resolved.She noted some early satiety but denies swallowing difficulty.She did have some generalized abdominal and right-sided pain while she was on antibiotics but reports it went away as soon as she finished them.The patient had persistent pain in her knees and had some concerns about a letter she received stating she may have been exposed to contaminated hylan g-f 20, sodium hyaluronate.She denied redness, swelling or warmth in either of her knees following the injections.She stated the pain has persisted and she does not feel like it helped in any way.She thought the pain may have worsened slightly.She had not yet followed up with orthopedics.Final diagnosis was not sleeping well, fatigue/feeling more tired, not applicable does not feel like it helped in any way, pain in knee, poor energy and not applicable device malfunction.It was not reported if the patient received a corrective treatment.Outcome: not recovered / not resolved for all other events except does not feel like it helped in any way and device malfunction.A product technical complaint (ptc) was initiated for synvisc, one batch number: 7rsl021.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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: medically significant for device malfunction.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8278417
• MDR Text Key: 134239280
• Report Number: 2246315-2019-00030
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• 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; Required Intervention
• Patient Weight: 76