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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 Problems Arthralgia (2355); Joint Swelling (2356)
Event Date 11/01/2017
Event Type  malfunction  
Event Description
This case is cross referred with case: (b)(4) (cluster). This unsolicited case from united states was received on (b)(6) 2018 from a medical doctor. This case concerns a female patient (age: not reported) who received treatment with synvisc one and after unknown latency had temperature after injection, pain after injection, warmth in the knee, swelling after injection and knee was aspirated (latency: 2 days). Also device malfunction was identified for the reported lot number. No past drugs, medical history, concurrent conditions or concomitant medications were reported. On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided) in right knee for knee pain. Patient did not receive any other injections prior to the synvisc-one and it was not sure if the patient was given an injection at the same time of the synvisc-one. On an unknown date, 2 day after receiving injection, patient was seen two days after the injection and was for complaints of pain and swelling. It was unknown if the patient engaged in any activities such as tennis or jogging soon after the injection. Patient was known to have pain and swelling in the affected knee. Measurements of the knee circumference was not known. It was unknown if the patient was able to bear weight before and after the injection. The level of pain that the patient complained of was unknown. It was unknown if the patient had a fever. Blood work was done but, results and specific type of lab work completed was unknown. Cultures were completed but, results of culture were unknown. The patient had been treated with corticosteroids. The patient had not been hospitalized yet, but the providers office noted that the patient may require surgery on the knee as a result of the injection. On an unknown date, after unknown latency, patient had pain, swelling and a temperature after the injection. Patient did not have fever results. On (b)(6) 2017, 2 days after receiving injection, patient's knee was aspirated. Patient did not have results of aspiration. Blood work was obtained days after the injection in the right knee. Patient was able to bear weight prior to the injection and after the injection. Patient was still having warmth in the knee, pain and swelling. Corrective treatment: corticosteroids for pain after injection, swelling after injection; aspiration for knee was aspirated (joint effusion); not reported for rest of the events. Outcome: not recovered for pain after injection, swelling after injection and warmth in the knee; unknown for rest of the events. 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: required intervention for device malfunction, pain after injection and swelling after injection. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018. This case concerns a patient who received synvisc-one injection from the recalled lot and later experienced fever, knee pain, knee swelling and warmth. 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
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key7288207
MDR Text Key101009925
Report Number2246315-2018-00329
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 health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/16/2018
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: 02/22/2018 Patient Sequence Number: 1
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