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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Cancer (3262); Swelling/ Edema (4577)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon receipt of new and relevant information and or upon completion of the investigation by the manufacturing plant.

Event Description

On 24may2022 medwatch (b)(4) was received by anika.It was reported that a 65 year old female patient experienced pain and peripheral swelling on an unspecified date after receiving an orthovisc injection.There was no report of a device malfunction.It was reported that the patient had been treated with rubraca (rucaparib) 300 mg once daily, orally from an unspecified date in mar2020 for malignant neoplasm of unspecified ovary.The patient's medical history was not reported.No concomitant medications were reported.At the time of the original medwatch report, the patient stated the pain was better and was now a 7 on a pain scale.In addition, the swelling went down a bit.Therapy with rubraca was maintained.The outcome of the reported event was resolving.The reporter did not assess the causal relationship between rubraca and the reported events.

Manufacturer Narrative

A supplemental report will be submitted upon receipt of new and relevant information and or upon completion of the investigation by the manufacturing plant.Additional information was not provided.A batch record review was not performed since the lot number and part number was not provided.There was no allegation of a device malfunction.A clinical assessment was performed on this case.According to the medwatch report a complaint was filed on march 24,2022 by a person who declined to be identified and also denied consent for further contact by the manufacturer to follow up on the complaint.In the fda medwatch report ( mw5108558), the event reported is described as ovarian cancer and treatment with chemotherapy.The suspect reported is intra articular orthovisc.There is no date of service provided to provide a temporal association.Based on a review of the complaint, there is insufficient information to evaluate this complaint further.A review of previous complaints for orthovisc, as well as a review of the risk profile does not support any association between the intra articular injection of orthovisc and the complaint of ovarian cancer.Addendum: additional brief information provided regarding this case suggests that the temporal association of orthovisc is post the diagnosis of ovarian cancer and chemotherapy.This case will be monitored and trended.A supplemental report will be submitted upon receipt of addtional and relevant information.

Event Description

On 24may2022 medwatch clo-2022-000497 was received by anika.It was reported that a 65 year old female patient experienced pain and peripheral swelling on an unspecified date after receiving an orthovisc injection.There was no report of a device malfunction.It was reported that the patient had been treated with rubraca (rucaparib) 300 mg once daily, orally from an unspecified date in (b)(6) 2020 for malignant neoplasm of unspecified ovary.The patient's medical history was not reported.No concomitant medications were reported.At the time of the original medwatch report, the patient stated the pain was better and was now a 7 on a pain scale.In addition, the swelling went down a bit.Therapy with rubraca was maintained.The outcome of the reported event was resolving.The reporter did not assess the causal relationship between rubraca and the reported events.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford 01730
• Manufacturer (Section G): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 14681389
• MDR Text Key: 294904649
• Report Number: 3007093114-2022-00006
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: CLO-2022-000497
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female