MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE; HYALURONIC ACID

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Rash (2033); Dizziness (2194); Wheal(s) (2241); Syncope/Fainting (4411); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported a patient experienced hives, rash, fainting, dizziness, and injection site swelling following intra-articular injection of durolane.
Additional Manufacturer Narrative
It was reported a patient experienced hives, rash, fainting, dizziness, and injection site swelling following intra-articular injection of durolane.Assessment by clinical affairs determined the event type is suspected to be a serious adverse event due to hospitalization following durolane injection.Hives and generalized rash are suggestive of systemic allergic reaction.Fainting and dizziness are possible anaphylactic reactions.The durolane instructions for use (ifu) specifies incidences of rash, hives, and dizziness have been reported in association with intra-articular injection.The ifu identifies hypersensitivity reactions (rash and swelling) as known risks, but the systemic reaction with hospitalization may be considered serious and reportable.No other patient details are provided, such as medical history and other list of medications, and no lot number has been provided.Given the lack of patient details, causality cannot be confirmed for product or procedure, but suspected adverse reaction is reasonable and is deemed as reportable.Attempts to complete interviews with the reporter to obtain additional details to support the investigation of the event are ongoing.
Event or Problem Description
As reported a patient was hospitalized with hives, rash, fainting, dizziness, and injection site swelling following intra-articular injection of durolane.
Additional Manufacturer Narrative
It was reported by a friend of the family that a patient experienced hives, rash, fainting, dizziness, and injection site swelling following intra-articular injection of durolane.The subject product lot number was not provided to support investigation of the associated production lot.Assessment by clinical affairs determined the event type is suspected to be a serious adverse event due to hospitalization following durolane injection.Hives and generalized rash are suggestive of systemic allergic reaction.Fainting and dizziness are possible anaphylactic reactions.The durolane instructions for use (ifu) specifies incidences of rash, hives, and dizziness have been reported in association with intra-articular injection.The ifu identifies hypersensitivity reactions (rash and swelling) as known risks, but the systemic reaction with hospitalization may be considered serious and reportable.Patient or procedure details such as relevant medical history and other list of medications were not provided.Attempts to acquire additional information to support the investigation of the event were unsuccessful.Therefore, causality cannot be conclusively confirmed for the product or procedure.Based on all information available, the most probable cause codes for the adverse events identified in the durolane risk assessment, e.G., hives, rash, injection site swelling are indeterminate.The most probable cause codes for the reported fainting and dizziness, likely an allergic-anaphylactic reactions are also indeterminate.No further investigatory actions will be taken within the complaint record.Complaints reported against durolane on issues related to hives, rash, allergic reaction(s) (fainting, dizziness), and injection site swelling will continue to be monitored to determine if additional actions associated with the reported issues may be indicated.

• Brand Name: DUROLANE
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): BIOVENTUS LLC; 4721 emperor blvd suite 100; durham NC 27703
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala, swe SWE-7 52 2; SW SWE-752 28
• Manufacturer Contact: william heard ; 4721 emperor blvd; suite 100; durham, NC 27703 ; 9194746802
• MDR Report Key: 23856108
• Report Number: 3009595577-2025-00006
• Device Sequence Number: 5081382
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: 00816986020808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170007/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1082020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown