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

Model Number 630-254

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Arthralgia (2355); Insufficient Information (4580)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported by the patient via phone that he receives 3 injections every year, but after a forth knee injection in september, patient can barely walk.A couple of weeks after the injection, the patient reported knee pain that developed to leg pain, finally to hip pain with inflammation.The patient has gone thru blood tests with clean results.The device is not available for evaluation.

Manufacturer Narrative

The lot number was not provided to the manufacturing plant.A batch record review could not be performed.The device was not returned to the plant.A supplemental report will be provided upon receipt of new and relevant information.

Event Description

Patient information provided.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 11140794
• MDR Text Key: 225815607
• Report Number: 3007093114-2021-00001
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 630-254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention