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

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

Patient Problems Dyspnea (1816); Fever (1858); Rash (2033); Chills (2191)

Event Date 11/04/2022

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 (b)(6) 2023 a patient of unknown age and demographics reported to anika of being misdiagnosed and received three injections of orthovisc.The first injection was on the right knee on (b)(6) 2022, the second injection was on the right knee on (b)(6) 2022 and the third injection was on the right knee on (b)(6) 2022.An xray was done for every injection.The patient reported that on (b)(6) 2022 of reporting to the emergency room with fever, chills, and fatigue.The patient also reported a severe rash over the entire body and difficulty breathing.The patient was reportedly treated with steroids.There was no report of any device malfunction or appearance issues at the time of each injection.The current status of the patient is unknown at this time.It is unknown when the patient was discharged from the emergency room.Anika also received notification of this case from the distributor on 31march2023.Additionally, two medwatch reports were received by anika from the fda.The medwatch numbers are (mw5116023 & mw5116022).Additional information has been solicited.

Manufacturer Narrative

This case is still under investigation by the manufacturing plant.Additional information has been solicited.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

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 24mar2023 a patient of unknown age and demographics reported to anika of being misdiagnosed and received three injections of orthovisc.The first injection was on the right knee on 09/29/22, the second injection was on the right knee on 10/12/2022 and the third injection was on the right knee on 10/17/2022.An xray was done for every injection.The patient reported that on 11/4/2022 of reporting to the emergency room with fever, chills, and fatigue.The patient also reported a severe rash over the entire body and difficulty breathing.The patient was reportedly treated with steroids.There was no report of any device malfunction or appearance issues at the time of each injection.The current status of the patient is unknown at this time.It is unknown when the patient was discharged from the emergency room.Anika also received notification of this case from the distributor on 31march2023.Additionally, two medwatch reports were received by anika from the fda.The medwatch numbers are (mw5116023 & mw5116022).Additional information has been solicited.

Manufacturer Narrative

This case is still under investigation by the manufacturing plant.Additional information has been solicited.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report.The reported event of a patient reaction was confirmed with photos provided which illustrated a patient reaction.However, there is insufficient information to show a temporal association between the use of the device and the patient' reaction.The case was reviewed by a clinician and concluded that the patient's knee bursitis may be related to some unreported underlying knee condition.The lot number was not provided; therefore a batch record review was not performed.All product manufactured by anika and anika entities are released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.

• 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 Key: 16744695
• MDR Text Key: 313343020
• Report Number: 3007093114-2023-00012
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention