MAUDE Adverse Event Report: BIOVENTUS LLC. DUROLANE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 20044

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/09/2022

Event Type  Injury  

Event Description

Pain in knees started approximately 8 hours after receiving injections.Started off worse in the right knee but now the pain is worse in the left.No reported swelling or bruising.Pt contacted mdo on (b)(6) 2022 and received a call back around 1 pm.Pt was instructed to take ibuprofen and that to call the mdo back if the pain has not gotten better in 2 days.The pt has not had any alleviation in the pain.Pt also has difficulty bending the knees due to increased pain.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 14430461
• MDR Text Key: 292046837
• Report Number: MW5109770
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130202001
• UDI-Public: 89130-2020-01
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 20044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2022
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ALBUTEROL SULFATE NEBULIZED SOLUTION; ALFUZOSIN ; ATORVASTATIN ; DICLOFENAC; FERROUS SULFATE; FEXOFENADINE; FLUTICASONE; FOLIC ACID; GABAPENTIN ; GLIPIZIDE; HYDROCHLOROTHIAZIDE; LORATIDINE; LOSARTAN ; MELATONIN ; METFORMIN ; NAPROXEN ; NITROGLYCERIN SUBLINGUAL; OMEPRAZOLE; SENNA
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian