MAUDE Adverse Event Report: ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION

Catalog Number	630254
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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.
Additional 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 performed.There were no nonconformance's 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 performed on all non conformance's associated with this product.There were no non conformance's 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.Supplemental submission: correction d4, included part number and udi number.A supplemental report will be submitted upon receipt of new and relevant information.
Event or Problem 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.

• Brand Name: ORTHOVISC
• Common Device Name: 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 Key: 17922702
• Report Number: 3007093114-2023-00088
• Device Sequence Number: 6782764
• Product Code: MOZ
• UDI-Device Identifier: 00817337000111
• UDI-Public: (01)00817337000111
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 630254
• Device Lot Number: 0000008133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 11/08/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/09/2023; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown