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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Cyst(s) (1800); Edema (1820); Erythema (1840); Fever (1858); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Reaction, Injection Site (2442); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 12/01/2017
Event Type  Injury  
Event Description
Based on additional information received on 12-feb- 2018, the case became medically confirmed (received form physician). This spontaneous case from united states was received on 02-jan-2018 from the patient this case concerns a (b)(6) year old female patient who initiated treatment with synvisc one and since the same day had terrible pain, couldn't walk for about 2 and half week, knee became unbendable, knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock; after an unknown latency had to use a walker for over 2 weeks after the injection, could not bear weight on knee and pulled fluid out of knee, also, device malfunction was identified for the reported lot number. No medical history, previous medications were reported. She takes thyroid medication, blood pressure pills, and a cholesterol pill. The patient had bladder surgery in 1990 and cataract surgery in 2013. The patient was allergic to mold and ragweed. Concomitant medications included atorvastatin calcium, levothyroxine sodium (synthroid), montelukast sodium and hydrochlorothiazide. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl021; expiry date: 31-may-2020) for degenerative joint disease. On the same day, the patient had knee pain after synvisc one injection. On the same day, knee became swollen, hard as a rock, and unbendable. She called the physician and was told to put ice on it and take aleve. On (b)(6) 2017, she saw her primary care physician near her home. Her pcp pulled 5 cc of fluid out of her knee and sent it for culture. The culture was negative for infection. She denies fever. She was told that she must have received product from the recalled lot, and she also has a letter from the clinic about the recalled lot. After receiving the injection, she could not bear weight on the knee and was in terrible pain. She says she has never had such pain. She had to use a walker for over 2 weeks after the injection. Currently, her knee is still swollen somewhat, and she can walk on it unassisted. After 30 to 45 minutes of being up around the house, her knee starts aching again. Only in the last few days had she been able to put weight on it. She is also able to bend it some now. As of (b)(6) 2018, it was reported that the patient still had problem of knee pain. The patient did not visit emergency room and was not admitted in the hospital. Corrective treatment: use a walker for had to use a walker for over 2 weeks after the injection, couldn't walk for about 2 and half week; aleve, ice for knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock, terrible pain; pulled 5 cc fluid out of knee pulled fluid out of knee outcome: not recovered for knee was swollen about 5 times bigger than usual/ knee became swollen, device malfunction, knee became hard as a rock, terrible pain, pulled fluid out of knee; recovered for had to use a walker for over 2 weeks after the injection and recovering for rest of the events a product technical complaint (ptc) was initiated with global ptc number: 51724 seriousness criteria: disability for had to use a walker for over 2 weeks after the injection and device malfunction. 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. Follow up information was received on 31-jan-2018. Global ptc number was added. Additional information was received on 12-feb-2018 form a physician (case became medically confirmed). The patient's concomitant medications, medical history were added. The suspect drug's indication was updated and expiration date was added. The event onset date for the event of had terrible pain was updated. Clinical course was updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 13-feb-2018: the follow received does not change the previous assessment of the case. This case concerns a female patient who received synvisc one injection from the recalled lot and later her knee became swollen, hard as rock, unbendable, was in terrible pain, could not walk and bear weight on her knee and had to use a walker for over 2 weeks after the injection. 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.
 
Event Description
This spontaneous case from united states was received on (b)(6) 2018 from the patient. This case concerns a (b)(6) female patient who initiated treatment with synvisc one and since the same day couldn't walk for about 2 and half week, knee became unbendable, knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock; after an unknown latency had to use a walker for over 2 weeks after the injection, could not bear weight on knee, had terrible pain and pulled fluid out of knee, also, device malfunction was identified for the reported lot number. No medical history, previous medications, concomitant medications were reported. She takes thyroid medication, blood pressure pills, and a cholesterol pill. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl021; expiry date: unknown). On the same day, knee became swollen, hard as a rock, and unbendable. She called the physician and was told to put ice on it and take aleve. On (b)(6) 2017, she saw her primary care physician near her home. Her pcp pulled 5 cc of fluid out of her knee and sent it for culture. The culture was negative for infection. She denies fever. She was told that she must have received product from the recalled lot, and she also has a letter from the clinic about the recalled lot. After receiving the injection, she could not bear weight on the knee and was in terrible pain. She says she has never had such pain. She had to use a walker for over 2 weeks after the injection. Currently, her knee is still swollen somewhat, and she can walk on it unassisted. After 30 to 45 minutes of being up around the house, her knee starts aching again. Only in the last few days had she been able to put weight on it. She is also able to bend it some now. Corrective treatment: use a walker for had to use a walker for over 2 weeks after the injection, couldn't walk for about 2 and half week; aleve, ice for knee was swollen about 5 times bigger than usual/ knee became swollen, knee became hard as a rock, terrible pain; pulled 5 cc fluid out of knee pulled fluid out of knee outcome: not recovered for knee was swollen about 5 times bigger than usual/ knee became swollen, device malfunction, knee became hard as a rock, terrible pain, pulled fluid out of knee; recovered for had to use a walker for over 2 weeks after the injection and recovering for rest of the events seriousness criteria: disability for had to use a walker for over 2 weeks after the injection and device malfunction 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. Pharmacovigilance comment: sanofi company comment dated 08-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot and later her knee became swollen, hard as rock, unbendable, was in terrible pain, could not walk and bear weight on her knee and had to use a walker for over 2 weeks after the injection. 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.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7208868
MDR Text Key286501317
Report Number2246315-2018-00079
Device Sequence Number0
Product Code MOZ
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/22/2018 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN (ACETAMINOPHEN),; ALBUTEROL [SALBUTAMOL] (ALBUTEROL [SALBUTAMOL]),; ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM),UNKNOW; ATORVASTATIN CALCIUM(CON.); ATORVASTATIN CALCIUM(CON.); HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE),; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE),UNKNOWN; HYDROCHLOROTHIAZIDE(CON.); HYDROCHLOROTHIAZIDE(CON.); LEVOTHYROXIN (LEVOTHYROXINE SODIUM),UNKNOWN; MONTELUKAST SODIUM (MONTELUKAST SODIUM),UNKNOWN; MONTELUKAST SODIUM(CON.); MONTELUKAST SODIUM(CON.); SYNTHROID (LEVOTHYROXINE SODIUM),UNKNOWN; SYNTHROID(CON.); SYNTHROID(CON.)
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