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

Catalog Number 630254

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

Patient Problem Bacterial Infection (1735)

Event Date 02/25/2023

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation at the manufacturing plant.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at 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 (b)(6) 2023 it was reported to anika that on (b)(6) 2023 the patient received the 4th injection of orthovisc.Orthoscan guidance was used.Patient received a full injection.Needle gauge used was 23.On (b)(6) 2023, the patient reported knee pain.The patient went golfing and was in and out of a sports car for the day.The patient stated he may have overdone it but declined to go to the er to undo the work already done.The patient subsequently reported to the er on v2023 and was admitted and discharged two days later.The patient was cultured , the results was not reported.Patient was in the past diagnosed with a staph infection so the patient was treated with vancomycin intravenously.The patient reportedly followed the post injection protocols.There was no report of any appearance issues with the product or packaging.There was no report of any device malfunction at the time of use.The product was stored at ambient temperature in a cabinet.Additional information has been solicited.

Manufacturer Narrative

This case is still under investigation at the manufacturing plant.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing plant.Supplemental report: the reported event is not confirmed.It was reported to anika by the distributor that after an orthovisc medial injection in the right knee on a 74 year old caucasian male patient, he experienced redness and swelling.The patient reportedly had an infection in the knee and had two drainages.The device was discarded.The patient was injected with a 23 gauge needle.This was the patient's 4th injection for hyaluronic acid.No fluids was removed prior to the injection and the patient had a full dose under orthoscan (fluoroscopy).The patient had the injection on (b)(6) 2023 and called on (b)(6) 2023 stating he had severe pain in the knee, he went golfing the same day he had the injection, went in and out of low sports car and was on his feet all day, and felt he had overdone it.Patient went to the emergency room (er), was admitted for an unspecified number of days.Release date was not provided.Patient's joint fluid was sent for culture and sensitivity but results was unknown.The patient was prescribed vancomycin which was administered intravenously.The patient had staph in the past that was treated with picc line.The current status of the patient is unknown.There was no report of any unusual appearance with the packaging or device at the time of use.There was no malfunction reported at the time of use of the device.The product was stored at room temperature in a cabinet.The clinical assessment concluded that there is no objective evidence provided to suggest infection and that the patient may have exacerbated the knee by playing golf on the same day as the injection.The batch record was reviewed.There was no nonconformances documented in the manufacturing record.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.A supplemental report will be submitted upon receipt of new and relevenat 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 14mar2023 it was reported to anika that on (b)(6) 2023 the patient received the 4th injection of orthovisc.Orthoscan guidance was used.Patient received a full injection.Needle gauge used was 23.On (b)(6) 2023, the patient reported knee pain.The patient went golfing and was in and out of a sports car for the day.The patient stated he may have overdone it but declined to go to the er to undo the work already done.The patient subsequently reported to the er on (b)(6) 2023 and was admitted and discharged two days later.The patient was cultured , the results was not reported.Patient was in the past diagnosed with a staph infection so the patient was treated with vancomycin intravenously.The patient reportedly followed the post injection protocols.There was no report of any appearance issues with the product or packaging.There was no report of any device malfunction at the time of use.The product was stored at ambient temperature in a cabinet.Additional information has been solicited.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 16689421
• MDR Text Key: 312778955
• Report Number: 3007093114-2023-00010
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 630254
• Device Lot Number: 0000007955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White