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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
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ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION Back to Search Results
Lot Number 0000008133
Device Problem No Apparent Adverse Event (3189)
Patient Problem Insufficient Information (4580)
Event Date 08/01/2023
Event Type  Injury  
Event Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 15 sept 2023 anika received a medwatch report (mw514271) from the fda.It was reported on the medwatch that a patient reported having a left knee replacement surgery on an unspecified date.It was reported that the patient had one injection into the left knee once a week, on an unspecified date(s).Orthovisc was listed as the product in the medwatch report.The medwatch report was marked as an adverse event.However, there was no specific adverse event reported for the orthovisc injection(s).It was not reported if the patient is alleging a temporal association between the use of orthovisc and the patient's left knee replacement.The pharmacy who reported the medwatch was contacted and when additional information was solicited, responded that the patient did not provide any consent to follow up.The patient also did not allege the orthovisc device(s) injections was the cause of the patient's left knee replacement.There was no report of a malfunction.The lot number was not reported.
 
Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
 
Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental submission.The reported event is not confirmed.The pharmacy who reported the initial medwatch provided the reported lot number but stated that the patient did not consent to provide additional information.There was no specific allegation of a device failure or that there was a temporal association between the use of the device and the patient's revision.The current status of the patient is unknown.A review of the product batch record was peformed.There were no nonconformances documented in the batch record.All product manufactured by anika and anika entities are released to applicable procedures and specifications.A three year retrospective review was peformed on all non conformances associated with this product.There were no non conformances documented that are related to this reported event.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.
 
Event Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 15 sept 2023 anika received a medwatch report (mw514271) from the fda.It was reported on the medwatch that a patient reported having a left knee replacement surgery on an unspecified date.It was reported that the patient had one injection into the left knee once a week, on an unspecified date(s).Orthovisc was listed as the product in the medwatch report.The medwatch report was marked as an adverse event.However, there was no specific adverse event reported for the orthovisc injection(s).It was not reported if the patient is alleging a temporal association between the use of orthovisc and the patient's left knee replacement.The pharmacy who reported the medwatch was contacted and when additional information was solicited, responded that the patient did not provide any consent to follow up.The patient also did not allege the orthovisc device(s) injections was the cause of the patient's left knee replacement.There was no report of a malfunction.The lot number was not reported.
 
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Brand Name
ORTHOVISC
Type of Device
SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
Manufacturer (Section D)
ANIKA
32 wiggins avenue
bedford MA 01730
Manufacturer Contact
keith kelly
32 wiggins avenue
bedford, MA 01730
MDR Report Key17922702
MDR Text Key325518439
Report Number3007093114-2023-00088
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 Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot Number0000008133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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