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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Fatigue (1849); Arthralgia (2355); No Code Available (3191)

Event Type  Injury  

Event Description

Device malfunction [device malfunction]; increased fatigue/feeling more tired [fatigue aggravated] ; not sleeping well [poor quality sleep]; poor energy [energy decreased]; pain in knee [pain in knee] ([pain aggravated]); does not feel like it helped in any way [device ineffective].Case narrative: initial information received from united states on 16-jan-2019 regarding an unsolicited valid serious malfunction case received from a lawyer.This case involves "an approximately" a (b)(6) year old female patient who developed increased fatigue/feeling more tired, not sleeping well, poor energy, pain in knee and does not feel like it helped in any way after receiving treatment with synvisc one.Device malfunction was identified for the reported lot number.The patient's past medical history included rhinitis allergic, anaemia, eczema, gastrooesophageal reflux disease, hyperlipidaemia, migraine with significant right sided nasal obstruction as possible etiology, vitamin d deficiency, non morbid obesity due to excess calories, caesarean section in 2010 and 2012, cholecystectomy, tonsillectomy and functional endoscopic sinus surgery.She has a history of vitamin d deficiency and states she has not been consistently taking her over-the-counter supplement.The patient felt much better when she was taking the once weekly prescription supplement.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing penicillin allergy, helicobacter pylori infection, epigastric pain, generalized abdominal and right-sided pain epigastric pain, arthralgia and non smoker.Concomitant medications included meloxicam (mobic); calcium carbonate, colecalciferol (caltrate 600+d); and magnesium oxide (mag-ox).On (b)(6) 2017, the patient started using intra-articular injection of synvisc one (at a dose of 6 ml dosage (lot - 7rsl021) for primary osteoarthritis of knees.On an unknown date in (b)(6) "0187" after unknown latency, the patient was not sleeping well.On (b)(6) 2017, it was reported that patient had pain in both knees and increased fatigue.Patient was concerned about fatigue, epigastric pain and vitamin d deficiency.The patient stated that she had been feeling more tired recently.The patient was also drained.She had poor energy.She denies weight gain/weight loss or heat/cold intolerance.The patient noted the epigastric pain but denies nausea or vomiting, diarrhea or constipation, melena or hematochezia.She was concerned about an ulcer and h.Pylori infection.She denies 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 synvisc 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 synvisc.She denies redness, swelling or warmth in either of her knees following the injections.She states the pain has persisted and she does not feel like it helped in any way.She thinks the pain may have worsened slightly.She has not yet followed up with orthopedics.Final diagnosis was not sleeping well, not applicable does not feel like it helped in any way, pain in both knees, poor energy, increased fatigue/feeling more tired and device malfunction.It was not reported if the patient received a corrective treatment.The patient outcome not recovered / not resolved for all other events except does not feel like it helped in any way.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.

• 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: 8278463
• MDR Text Key: 134186544
• Report Number: 2246315-2019-00028
• 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: No Information
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 77