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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Arthritis (1723); Aspiration/Inhalation (1725); Fatigue (1849); Hyperglycemia (1905); Hypersensitivity/Allergic reaction (1907); Chills (2191); Arthralgia (2355); Joint Disorder (2373); No Code Available (3191)
Event Date 11/16/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]; allergic reaction [allergic reaction] ; non-gout non-pseudogout noninfectious arthritis [arthritis] ([knee swelling], [condition worsened], [joint warmth], [knee pain]); joint effusion [joint effusion] ; chills [chills] ; mild to moderate decrease in urination [urine volume decreased] ; not feeling well [feeling unwell] ; hyperglycemia [hyperglycemia] ; mild increase in fatigue [fatigue] ; case narrative: initial information received on 16-jan-2019 from united states regarding an unsolicited valid legal serious case received from a lawyer. This case involves a (b)(6) male patient who experienced non-gout non-pseudogout noninfectious arthritis, joint effusion, chills, mild to moderate decrease in urination, allergic reaction, hyperglycemia and mild increase in fatigue after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) and methylprednisolone acetate (depo-medrol). Additionally, the event of device malfunction was also reported. The patient's past medical history included pain and swelling of left lower extremity, effusion of knee joint, left, ankle effusion, gouty arthritis, osteoarthrosis, localized, primary, involving lower leg, acute medial meniscal tear, right, subsequent encounter, acute pain of right knee, dvt (deep venous thrombosis), thyroid disease, blood clot, hypercholesterolemia, allergy to penicillin, gallbladder surgery, foot surgery, other surgery, diabetes mellitus, hyperlipidaemia, meniscus degeneration, pulmonary embolism, sleep apnea, cholecystectomy, colectomy partial/total on (b)(6) 2015, elbow surgery, hernia repair, tonsillectomy, vena cava filter insertion on (b)(6) 2015 and arthroscopic medial meniscectomy of the right knee. He also had surgery of tonsils and adenoids. His family history included cerebrovascular accident, depression and diabetes mellitus with mother. His past medical treatment(s), vaccination(s) was not provided. Concomitant medications included azithromycin, cetirizine hcl, fluticasone propionate, sertraline hcl, hydrocodone bitartrate, paracetamol (norco), ondansetron hydrochloride (zofran), tramadol hcl, cefalexin (cephalexin), diclofenac sodium, testosterone (androderm), sitagliptin phosphate (januvia), rivaroxaban (xarelto), pantoprazole sodium, pravastatin sodium, ranitidine hcl, lithium carbonate, methimazole and meloxicam (mobicam). Concurrent conditions were having discomfort medially and anteriorly, was non-smoker and alcohol use the occasional drink per day. On (b)(6) 2017, the patient took using hylan g-f 20, sodium hyaluronate, injection of unknown dosage for once only via intra-articular route (lot - 7rsl021) for chondromalacia patella and osteoarthritis. It was reported that felt good for a couple of hours, and then the knee ballooned up with intense pain. His wife reported the swelling was extensive and he was in severe pain. On the night of (b)(6) 2017, patient reported the right knee swelling. He also that he felt chills and abnormal swelling to his right knee with warmth that was constantly progressing and mild pain to the back of right knee. They went to the emergency room last night ((b)(6) 2017) and the er doctor performed an arthrocentesis. The needle was placed from the medial side of the knee and he was able to remove 50 cc of yellow fluid and then they were still concerned about it because it was still swollen, and he was still having some degree of pain. Later on, the same day, it was also seen that 40 cc of yellow fluid was removed and depo-medrol was instilled. It was also reported that patient had an allergic reaction probably due to injection. The patient presents the emergency department with worsening knee swelling 24 hours after receiving intra-articular injection for pain. It was observed that knee was warm compared to the opposite side. Given his systemic symptoms of chills and not feeling well were previously considered the possibility of septic arthritis. Synovial fluid analysis showed only 13,000 white blood cells and per discussion with physician, patient was unlikely to represent septic arthritis. As per discussion patient was prescribed with meloxicam and there was no indication for antibiotics he had been asked to return to the emergency department for worsening pain redness warmth fever or any other symptoms or concerns or failure to improve. There was no evidence of gout or pseudogout. There was no evidence of trauma. Non-gout non-pseudogout noninfectious arthritis was a consideration. On (b)(6) 2017, the lab test results showed that chloride was 111, glucose was 266, protime was 15. 4 and inr was 1. 20. Which indicated that these metabolic parameters were abnormal. On (b)(6) 2017, when patient presented to the healthcare facility, it was reported that hyperglycemia and reported mild to moderate decrease in urination. Patient notes recorded blood sugar of 472 last night ((b)(6) 2017) and 550 on (b)(6) 2017, and reported normal blood sugar range of below 200. It was reported that patient stated that he felt pretty good but reported a mild increase in fatigue. Patient reported receiving steroid injection as well as 2-3 arthrocentesis knee secondary to pain several days ago. Patient was currently taking xarelto daily. Patient's glucose was generally relatively well controlled in the range of 200, however over the last several days he reported that accu-cheks read within 4-500. He was not ketotic. He was not acidotic. He was encouraged to have close follow-up with his primary care physician. Patient was comfortable with this plan of care er. Final diagnosis was device malfunction, joint effusion, chills, non-gout non-pseudogout noninfectious arthritis, mild to moderate decrease in urination, hyperglycemia, allergic reaction and mild increase in fatigue corrective treatment: methylprednisolone acetate (depo-medrol) for the non-gout non-pseudogout non-infectious arthritis and allergic reaction outcome: unknown for joint effusion, non-gout non-pseudogout noninfectious arthritis, chills, hyperglycemia, right knee swelling, decrease in urination, allergic reaction and mild increase in fatigue. 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: intervention required for device malfunction, arthritis, joint effusion and allergic reaction.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key8278545
MDR Text Key134182354
Report Number2246315-2019-00031
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
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 Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/25/2019 Patient Sequence Number: 1
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