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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); Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)
Event Type  malfunction  
Event Description
This spontaneous case from united states was received on 09-feb-2018 from patient. This case concerns (b)(6) female patient who initiated treatment with synvisc one and after unknown latency patient walked on tread mill before synvisc-one injections, not after recalled injections, right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain before recalled injections almost the same but not quite, measured her left knee after recalled injection and it was 1" larger/both feet are slightly puffy. Also device malfunction was noted for the reported lot number. No previous medications, concomitant medications and concurrent conditions were reported. Patient had a pacemaker. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once bilateral for arthritis (batch/ lot number: 7rsl021 and expiry date: unknown). Consumer's right knee hurt after the injection, the left knee felt better for the first 24 hours, then both knees hurt worse each day down to the shin bone. Consumer didn't want to stand up or walk on her legs due to the pain, and husband pulls her up out of a chair. Consumer walked on tread mill before synvisc-one injections, not after recalled injections; she measured her left knee after recalled injection and it was 1" larger. Consumer denied swelling or redness of the right knee, both feet are slightly puffy. Consumer was weight bearing before recalled injections and weight bearing when necessary after recalled injections. Consumer denied using support devices before or after recalled injections. Consumer used diclofenac sodium topical gel 1% a dozen times a day and every hour at night for pain. Patient reported that she had not recovered and had constant pain. She denied fever, lab work, hospitalization. Consumer had taken a few aspirin for pain after injections. Corrective treatment: diclofenac sodium topical gel 1%, aspirin for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain before recalled injections almost the same but not quite; not reported for other outcome: not recovered for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain before recalled injections almost the same but not quite and device malfunction; unknown for other events. Seriousness criteria: important medical event for 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 15-feb-2018: this case concerns a female patient who received treatment with a recalled lot of synvisc one and experienced decreased mobility, swelling if limbs and knee pain. The role of the device cannot be denied for the occurrence of the event based upon the available information. Further the concerned lot number has been identified to have malfunction. Therefore, the causal role of the device in the development of events cannot be denied.
 
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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 Key7285186
MDR Text Key100924807
Report Number2246315-2018-00325
Device Sequence Number0
Product Code MOZ
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/09/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/21/2018
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2018
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: 02/21/2018 Patient Sequence Number: 1
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