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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 Problem Device Contamination With Biological Material (2908)
Patient Problem No Code Available (3191)
Event Date 11/07/2017
Event Type  malfunction  
Event Description
Based on the information received on 10-apr-2018 the case became medically confirmed and the case was upgraded to serious as the serious event of device malfunction was added and the seriousness for the event of difficulty walking/mostly not walking now/limp/can't walk still/now is only able to walk with a walker was updated. This unsolicited legal case from united states was received on (b)(6) 2018 from the other non health care professional (patient's attorney). This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after few hours the patient had high white blood cell count, difficulty walking/mostly not walking now and drain the knee/aspiration of left knee; on the same day had worsening of pain in her left knee/pain is burning and deep/left knee pain that is worse now than earlier/ right knee pain, right knee swelling, genu varum, patella shifted laterally, limited and crepitus motion, pain at initiation of movement and at extreme limits of range and limited; after 20 days was unable to bend her left knee/limited range of motion secondary to pain; after an unknown latency had tenderness of the lateral patellar facet and the medial patellar facet, sed rate sightly elevated, crp are slightly elevated, fatigue, fever, weight gain (10lbs), chest pain on exertion, shortness of breath when lying down, cough, wheezing, dizziness, frequent or severe headaches, runny nose, sinus pain/pressure/nose/sinus problems (sinus pain and sinus pressure). A device malfunction was noted for reported lot number. The patient does have a history of having received a hyaluronan product derived from rooster combs a long time ago without complication. Patient had bleeding disorder, genitourinary disease, tia, alzheimer's disease, gastrointestinal disorder, thyroid disorder, cesarean section, diabetes mellitus, congestive heart failure, obesity, drug allergy and bilateral knee osteoarthritis. Patient does not have any history of allergy to chicken, feathers, eggs, or bird protein. Patient does not have any prosthetic devices. Concomitant medications included: hydrocodone, paracetamol (acetaminophen) and lidocaine. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection (dose, frequency, indication: not reported) (batch lot number: 7rsl021; expiration date: may-2020) in the knee. The same day, the patient began to experience adverse symptoms by the time she got home, about an hour or two after the synvisc one injection. The adverse symptoms that the patient experienced and was continuing to experience were difficulty walking, high white blood cell count and they were going to drain the patient's knee this week. Patient was mostly not walking now, but when she does walk, it was with assistance (assistance device unspecified). On the same day, patient experienced worsening of pain in her left knee, pain was burning and deep, her left knee pain was worse now than earlier and also had right knee pain, right knee swelling, genu varum, she felt like her patella shifted laterally, limited and crepitus motion, pain at initiation of movement and at extreme limits of range and limited. The patient had been referred to an infectious disease specialist who withdrew fluid from knee and the same was sent to lab for testing. The reporter stated that previously, the patient had seen a neurosurgeon/neurologist, and a vascular surgeon, but was referred back to her orthopedist. The reporter stated that the patient was not hospitalized and he did know if the patient had experienced fever or not. On (b)(6) 2017 after a latency of 20 days was unable to bend her left knee and had limited range of motion secondary to pain. On an unknown date after an unknown latency patient had tenderness of the lateral patellar facet and the medial patellar facet, sed rate sightly elevated, crp are slightly elevated, fatigue, fever, weight gain (10lbs), chest pain on exertion, shortness of breath when lying down, cough, wheezing, dizziness, frequent or severe headaches, runny nose, sinus pain/pressure/nose/sinus problems (sinus pain and sinus pressure). Corrective treatment: rooster injection, walker for difficulty walking/mostly not walking now/limp/can't walk still/now is only able to walk with a walker; drain the knee for drain the knee/aspiration of left knee; tramadol for worsening of pain in her left knee/pain is burning and deep/left knee pain that is worse now than earlier/right knee pain; not reported for other events outcome: recovering for worsening of pain in her left knee/pain is burning and deep/left knee pain that is worse now than earlier/right knee pain; not recovered for unable to bend her left knee/limited range of motion secondary to pain; unknown for other events seriousness criteria: disability for difficulty walking/mostly not walking now/limp/can't walk still/now is only able to walk with a walker and device malfunction. A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) 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. Additional information was received on 20-feb-2018. Investigation summary results were received and added. Clinical course was updated. Text was amended accordingly. Additional information was received on (b)(6) 2018 from healthcare professional. Events of worsening of pain in her left knee/pain is burning and deep/left knee pain that is worse now than earlier/right knee pain, right knee swelling, genu varum, patella shifted laterally, limited and crepitus motion, pain at initiation of movement and at extreme limits of range and limited, unable to bend her left knee/limited range of motion secondary to pain, tenderness of the lateral patellar facet and the medial patellar facet, sed rate sightly elevated, crp are slightly elevated, fatigue, fever, weight gain (10lbs), chest pain on exertion, shortness of breath when lying down, cough, wheezing, dizziness, frequent or severe headaches, runny nose, sinus pain/pressure/nose/sinus problems (sinus pain and sinus pressure) and device malfunction was added. Case was upgraded to serious and case became medically confirmed. Concomitant medication and medical history was added. Clinical course was updated and text amended accordingly. Pharmacovigilance comment: sanofi company comment dated 10-apr- 2018: based on the available information, temporal relationship can be established between the events and suspect product. 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
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key7479932
MDR Text Key107863474
Report Number2246315-2018-00460
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/02/2018 Patient Sequence Number: 1
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