MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE; HYALURONIC ACID

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported by the physician, after the injection of the durolane product into the left hip with simultaneous administration of an nstride aps procedure, the patient had immediate onset of severe pain.The patient was admitted to the hospital as per standard procedure in canada and received morphine for pain management.Multiple follow-up attemtps were made and limited information was provided.The physician was unable to disclose any comorbidities or medications of the patinet.The physician confirmed that no cultures were taken and no medications were prescribed to the patient.The current patient status is unknown.
Event or Problem Description
It was reported a patient injected with the durolane product experienced immediate onset of severe pain.The patient was admitted to the hospital as per standard procedure in canada and received morphine for pain management.The patient was diagnosed with acute synovitis.The patient had blood drawn on four consectutive days, with the results showing elevated blood counts three times and returning to normal levels on the fourth drawn.No cultures were taken of the affected area, and no antibiotics were prescribed.The patient was discharged after seven days and has a follow up appointment scheduled with the physician.
Additional Manufacturer Narrative
Additional information: a batch record review was completed on the lot number provided.There were no deviations or anomalies during the manufacturing process, and the product met all specifications prior to release.No additional information has been received.Correction: b4 initial date of this report corrected.

• 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 SE-75 2 28; SW SE-752 28
• Manufacturer Contact: lizzie fields ; 4721 emperor blvd.; suite 100; durham, NC 27703 ; 9194746802
• MDR Report Key: 20290540
• Report Number: 3009595577-2024-00005
• Device Sequence Number: 7199498
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: (01)00816986020808(17)301126(10)22143
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P170007/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 1082013
• Device Lot Number: 22143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NSTRIDE APS
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female