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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Fatigue (1849); Fever (1858); Chills (2191); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Type  Injury  
Event Description
Unable to walk up/down stairs [unable to walk]; device malfunction [device malfunction] ; suspect microbial infection [joint infection] ; completes very difficult weight on my right leg [weight bearing difficulty]; fatigued [fatigue]; difficulty sleeping at night [difficulty sleeping] ; fevers [fever]; chills [chills] ; lack stamina [loss of energy] ; took out 8 cc of fluid [joint aspiration]; right knee warm to touch [injection site joint warmth]; mild effusion in the right knee [knee effusion] ; lot of pain/ right knee pain [knee pain] ([condition aggravated]); swelling in right knee [knee swelling]. Case narrative: initial information received on 07-feb-2019 regarding an unsolicited valid serious legal case received from a lawyer. This case involves a (b)(6) years old male patient who experienced device malfunction, suspect microbial infection, right knee warm to touch, lot of pain/ right knee pain, swelling in right knee, completes very difficult weight on my right leg, chills, fevers, took out 8 cc of fluid, increased pain, mild effusion in the right knee, fatigued, difficulty sleeping at night and unable to walk up/down stairs, while he used medical device hylan g-f 20, sodium hyaluronate (synvisc one). Also, device malfunction was identified for the reported lot number. The patient's past medical history included atrial fibrillation, aortic valve replacement, nasal polyps, retinopexy, thyroidectomy, arthralgia, lactose intolerance with gi upset reactions- diarrhea and abdominal pain, dermatitis contact with reaction- itching irritation, rubber sensitivity, haematuria, chest pain, prostatitis, bronchitis, urinary tract infection, asthenia, urinary tract obstruction, anemia, cough and hypersensitivity. 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 prostate cancer and erectile dysfunction. Concomitant medications included warfarin sodium (coumadin); paracetamol (tylenol); amlodipine besilate (norvasc); acetylsalicylic acid (aspirin); ciprofloxacin hcl; celecoxib (celexa); cyanocobalamin (vitamin b12); diazepam (valium); diazepam; doxycycline; finasteride (proscar); fluticasone propionate (flonase); levofloxacin (levaquin); levothyroxine sodium (synthroid); lorazepam (ativan); olopatadine hydrochloride (pataday); prednisone (deltasone); and tamsulosin hydrochloride (flomax). On (b)(6) 2017, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate), injection via intra-articular route (dosage unknown, lot - 7rsl021) for osteoarthritis and arthritis in both knees. On the next day, the patient experienced lot of pain/right knee pain (arthralgia), fever (pyrexia), chills, 1 day following the use of hylan g-f 20 and sodium hyaluronate. The pain was ice pick in intensity. Also, device malfunction was identified for the reported lot number. On (b)(6) 2017, the patient started using cane to ambulate (walking aid user) 2 days after use of hylan g-f 20 and sodium hyaluronate. On an unknown day, the patient had swelling in right knee (joint swelling) specifically. On (b)(6) 2017, patient had encounter with the physician and reported severe pain rating from 5 to 8 and to the point that he had difficulty sleeping at night because of the intensity of pain waking him up. The right knee and calf continue to be swollen, resident, and occasionally warm to the touch (injection site joint warmth). On (b)(6) 2018, the patient had 8 cc of fluid (aspiration joint) done. On an unknown date, the patient complained that he completed very difficult weight on his right leg (weight bearing difficulty). On an unknown date, the patient experienced increased pain (condition aggravated) and mild effusion in the right knee (joint effusion), fatigued (fatigue), difficulty sleeping at night (insomnia), lack stamina (asthenia), unable to walk up/down stairs (gait inability). On an unknown date, the patient developed an event of a serious suspect microbial infection (arthritis bacterial) after starting use of hylan g-f 20 and sodium hyaluronate. Relevant laboratory test results included: aspiration joint - on (b)(6) 2018: [result pending]. Culture - in (b)(6) 2017: [negative]. X-ray limb - on (b)(6) 2018: [bone on bone lateral compartment arthritic changes. Mild to moderate reduction in the patellofemoral articulation]. Final diagnosis was increased pain, fevers, chills, lot of pain/ right knee pain, suspect microbial infection, unable to walk up/down stairs, difficulty sleeping at night, fatigued, mild effusion in the right knee, took out 8 cc of fluid, completes very difficult weight on my right leg, swelling in right knee, right knee warm to touch and device malfunction. The patient was treated with ciprofloxacin (cipro). Outcome: not recovered / not resolved on an unknown date for chills, as recovered / resolved on fever, mild effusion in the right knee, difficulty sleeping at night; unknown for rest of the events. A product technical complaint was initiated for synvisc on with lot 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 was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Seriousness criteria- medically significant, disability for device malfunction; disability for unable to walk up/down stairs; medically significant for suspect microbial infection.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8344544
MDR Text Key136524699
Report Number2246315-2019-00051
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
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: 02/15/2019 Patient Sequence Number: 1
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